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This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals.
Patients were randomized to receive either 4-factor PCC (Octaplex) or frozen plasma (FP). The study compared the hemostatic treatment response to Octaplex versus FP, defined as effective if no additional systemic or surgical hemostatic intervention is required from 60 minutes to 24 hours after initiation of the first treatment dose. The study includes adult (≥18 years old) patients who underwent cardiac surgery with cardiopulmonary bypass (CPB) and required coagulation factor replacement due to bleeding post-CPB and after adequate reversal of heparin with protamine (as assessed by the surgical staff based on clinical and laboratory criteria) during surgery, and who have a known (e.g., as indicated by INR) or suspected coagulation factor deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octaplex | Experimental | Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing >60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if >60 kg). Octaplex: Prothrombin complex concentrate |
|
| Frozen plasma | Active Comparator | Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing >60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if >60 kg). Frozen Plasma Product, Human |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octaplex | Drug | Prothrombin complex concentrate |
| |
| Frozen Plasma Product, Human |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Requiring Additional Hemostatic Intervention | Defined as 'effective' if no additional hemostatic intervention, such as administration of any systemic hemostatic agents (including platelets, cryoprecipitate, fibrinogen concentrate, activated recombinant factor VII [rFVIIa], other coagulation factor products or a second dose of IMP) or any hemostatic interventions (including surgical re-opening for bleeding) is required from 60 minutes to 24 hours after initiation of the first dose of IMP. | 60 minutes to 24 hours after first dose of IMP |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Global Hemostatic Response Based on Requirement of Additional Hemostatic Intervention and Decreased Hemoglobin Levels | Defined as 'positive' if no additional hemostatic intervention is required and hemoglobin levels decrease by <30% (after accounting for red cell transfusions) from 60 minutes to 24 hours after initiation of the first dose of IMP. | 60 minutes to 24 hours after first dose of IMP |
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Inclusion Criteria:
Adult (≥18 years old) patients undergoing any index cardiac surgery employing CPB
Coagulation factor replacement with PCC or FP ordered in the operating room for:
Coagulation factor deficiency, either known to exist (e.g., as indicated by elevated EXTEM clotting time [CT] or INR) or suspected based on the clinical situation
Patients who have given written informed consent. In United States patients will provide informed consent prior to surgery. In Canada, informed consent will be obtained after surgery, in accordance with Article 3.7A of the 2018 Tri- Council Policy Statement on the Ethical Conduct for Research Involving Humans.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27710 | United States | ||
| University of Oklahoma Health Sciences Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42404094 | Derived | Tanaka KA, Butt AL, Stewart KE, Pezeshki G, Werner S, Bartoszko J, Ghadimi K, Solomon C, Vandyck K, Levy JH, Callum JL, Knaub S, Hegener O, Karkouti K. The association of estimated citrate load with frozen plasma versus four-factor prothrombin complex concentrate for coagulopathy after cardiac surgery: a post hoc exploratory analysis of the FARES-II randomised controlled trial. BJA Open. 2026 Jun 29;19:100577. doi: 10.1016/j.bjao.2026.100577. eCollection 2026 Sep. | |
| 40156829 |
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Of 538 enrolled participants, 420 met the inclusion criteria and were randomized to treatment.
Participants were recruited based on physician referral at 10 Canadian sites and 2 US sites. The first participant was enrolled in November 2022 and the last patient completed the study in June 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Octaplex | Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing >60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if >60 kg). Octaplex: Prothrombin complex concentrate |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 25, 2023 | Jun 27, 2025 |
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Given the physical differences in the products and the emergency nature of the intervention, attending clinicians present during the infusion of the blood products/components were not blinded to the treatment. To minimize bias, treating clinicians were blinded to group assignments until immediately prior to IMP infusion. The sponsor and data management teams were also blinded to treatment group allocations
| Drug |
If additional treatment is required after the maximum dose of IMP is administered or the treatment period has elapsed, patients in both groups will receive frozen plasma |
|
| Compare the Amount of Chest Tube Drainage Between the Octaplex and FP Groups. | 12 and 24 hours after chest closure |
| Compare the Incidence of Severe to Massive Bleeding Between the Octaplex and FP Groups Using a Modification of the Universal Definition of Perioperative Bleeding (UDPB). | Yes or no refers to whether severe to massive bleeding was present. | 24 hours after surgery start, after the end of CPB and after IMP initiation |
| Compare Efficacy in Terms of the Mean Number of Total Allogeneic Blood Products (ABPs) (IMP and Non-IMP) Transfused Between the Octaplex and FP Groups. | First 24 hours after the end of CPB |
| Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Products Transfused Between the Octaplex and FP Groups. | First 24 hours after the end of CPB |
| Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. | First 24 hours and 7 days after IMP initiation |
| Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. | 24 hours and 7 days after start of surgery, and after the end of CPB and after IMP initiation |
| Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. | 24 hours and 7 days after start of surgery and after the end of CPB and after IMP initiation |
| Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups | 24 hours and 7 days after the start of surgery, after the end of CPB and after IMP initiation |
| Compare Incidence of Intracerebral Hemorrhage Between the Octaplex and FP Groups | 24 hours after start of surgery, after the end of CPB and after IMP initiation |
| Compare Incidence of Gastrointestinal Hemorrhage Between Octaplex and FP Groups | 24 hours after start of surgery, after the end of CPB and after IMP initiation |
| Compare Incidence of Surgical Re-exploration Between Octaplex and FP Groups | 24 hours after start of surgery, after the end of CPB and after IMP initiation |
| Comparison of the Effect of Octaplex Versus FP Administration on the Change in International Normalised Ratio (INR) Before and After Therapy Administration. | The international normalized ratio (INR) is a standardized measure of prothrombin time (PT), ensuring consistency in results across different laboratories. The normal range for INR is around 0.8 to 1.2. Higher INR values indicate a slower clotting time and are associated with bleeding. Effective procoagulant therapy can reduce/normalize the INR. INR reduction was considered successful if the magnitude of the reduction was >1.0 or the post-treatment level dropped below 1.5 (INR >1.5 indicates that one or more coagulation factor levels are below the 30% critical threshold) | Within 30 minutes before to 60 minutes after the initiation of IMP administration. |
| Comparison of the Effect of Octaplex Versus FP Administration on the Change in Prothrombin Time (PT) | The prothrombin time (PT) measures the time it takes for clotting to occur, primarily assessing the extrinsic pathway of the coagulation cascade. Normal PT values range from 9 to 13 seconds. Higher PT values indicate a prolonged clotting time, suggesting potential issues with clotting factors such as fibrinogen, factors V, VII, and X and prothrombin, and are associated with bleeding. Effective procoagulant therapy can reduce/normalize the PT. | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
| Comparison of the Effect of Octaplex Versus FP Administration on the Change in Activated Partial Thromboplastin Time (aPTT) | Activated partial thromboplastin time (aPTT) is a standard laboratory test that measures how long it takes (in seconds) for clotting to occur (in the presence of an activator). It evaluates the intrinsic and common pathways of the coagulation cascade, assessing factors such as VIII, IX, XI, and XII, as well as fibrinogen. Prolonged aPTT may signify deficiencies in these clotting factors and is associated with bleeding. Effective procoagulant therapy can shorten/normalize the aPTT. | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
| Comparison of the Effect of Octaplex Versus FP Administration on the Change in Fibrinogen Activity | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
| Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM EXTEM CT | A rotational thromboelastometry (ROTEM; Werfen) device can be used at the bedside to rapidly assess the patient's coagulation status. Different viscoelastic tests can be performed to assess the dynamics of clot formation and lysis. Specifically, the EXTEM test is activated with tissue factor and evaluates the extrinsic coagulation pathway, with clotting time (CT) providing a measure (in seconds) of how quickly a clot starts forming. Prolonged EXTEM CT is associated with bleeding. Effective procoagulant therapy can reduce/normalize the EXTEM CT. | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
| Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM EXTEM MCF | A rotational thromboelastometry (ROTEM; Werfen) device can be used at the bedside to rapidly assess the patient's coagulation status. Different viscoelastic tests can be performed to assess the dynamics of clot formation and lysis. Specifically, the EXTEM test is activated with tissue factor and evaluates the extrinsic coagulation pathway, with maximum clot firmness (MCF) providing a measure (in mm) of the strength of the clot. Reduced EXTEM MCF is associated with bleeding. Effective procoagulant therapy can increase/normalize the EXTEM MCF. | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
| Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM FIBTEM MCF | A rotational thromboelastometry (ROTEM; Werfen) device can be used at the bedside to rapidly assess the patient's coagulation status. Different viscoelastic tests can be performed to assess the dynamics of clot formation and lysis. Specifically, the FIBTEM test evaluates fibrin-based clotting - it is extrinsically activated with tissue factor and additionally incorporates an inhibitor to eliminate the contribution of platelets to clotting. Maximum clot firmness (MCF) in the FIBTEM test provides a measure (in mm) of the strength of the fibrin-based clot. Reduced FIBTEM MCF is associated with bleeding. Effective procoagulant therapy to restore fibrinogen can increase/normalize the FIBTEM MCF. | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
| Comparison of the Effect of Octaplex Versus FP Administration on the Change in Platelet Count Measured by Plateletworks | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
| Comparison of the Effect of Octaplex Versus FP Administration on the Change in Platelet Function Measured by Plateletworks | The Plateletworks device (Helena Laboratories) enables rapid bedside screening of platelet function. The system uses an impedance cell counter and Plateletworks reagent tubes to evaluate platelet function and monitor treatment effects. By comparing a baseline total platelet count against the platelet count measured in the presence of an agonist used to stimulate platelet aggregation (ADP, collagen, or arachidonic acid), the tests determine the percent aggregation or inhibition of functional platelets. Manufacturer reference ranges, determined by testing blood samples from healthy volunteers, are 86-100% for ADP, 70-100% for collagen, and 60-100% for arachidonic acid. Values within these ranges indicate 'normal (positive)' platelet aggregation, which is important for clotting; lower values may be considered 'abnormal (negative)' and reflective of platelet inhibition. The manufacturer advises each laboratory to establish their own reference ranges for their patient population. | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
| Comparison of Total Time Elapsed From Initiation of the First Dose of IMP to Arrival Into the ICU Between the Octaplex and FP Groups. | From initiation of IMP to arrival at ICU room (within 24 hours) |
| Comparison of Incidence of Serious Treatment-emergent Adverse Events Between Octaplex and FP Groups | From the beginning of surgery up to postoperative day 30 |
| Comparison of the Duration of Mechanical Ventilation Between Octaplex and FP Groups | From the beginning of surgery up to postoperative day 30 |
| Comparison of the Duration of ICU Stay Between Octaplex and FP Groups | From the beginning of surgery up to postoperative day 30 |
| Comparison of the Duration of Hospitalization Between Octaplex and FP Groups | From the beginning of surgery up to postoperative day 30 |
| Comparison of the Incidence of Death Between Octaplex and FP Groups | Up to 30 days after the end of CPB |
| Comparison of the Number of Days Alive and Out of Hospital Between Octaplex and FP Groups | From the beginning of surgery up to postoperative day 30 |
| Oklahoma City |
| Oklahoma |
| 73104 |
| United States |
| Royal Columbian Hospital | New Westminster | British Columbia | V3L 3W7 | Canada |
| University of British Columbia and Vancouver Coastal Health Authority | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Hamilton Health Sciences Corporation | Hamilton | Ontario | L8L 8E7 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| London Health Sciences | London | Ontario | N6A 5A5 | Canada |
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| Sunnybrook Hospital | Toronto | Ontario | M4N 3M5 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Quebec Laval | Québec | Quebec | G1V 4G5 | Canada |
| Derived |
| Karkouti K, Callum JL, Bartoszko J, Tanaka KA, Knaub S, Brar S, Ghadimi K, Rochon A, Mullane D, Couture EJ, Lin Y, Harle C, Zeller M, Tran DTT, Solomon C, Rao V, Law M, Butt AL, Chen EP, Martins MR, Saha T, Shih AW, Vezina MC, Moussa F, Pereira Cezar Zamper R, Syed S, Buyukdere H, Werner S, Grewal D, Wong D, Vandyck KB, Tanzola R, Hughes B, Royer O, Wong S, Levy JH; FARES-II Study Group. Prothrombin Complex Concentrate vs Frozen Plasma for Coagulopathic Bleeding in Cardiac Surgery: The FARES-II Multicenter Randomized Clinical Trial. JAMA. 2025 May 27;333(20):1781-1792. doi: 10.1001/jama.2025.3501. |
| 39174056 | Derived | Karkouti K, Callum J, Bartoszko J, Solomon C, Knaub S, Levy JH, Tanaka KA; FARES-II Study Group. Protocol for a phase 3, randomised, active-control study of four-factor prothrombin complex concentrate versus frozen plasma in bleeding adult cardiac surgery patients requiring coagulation factor replacement: the LEX-211 (FARES-II) trial. BMJ Open. 2024 Aug 21;14(8):e091381. doi: 10.1136/bmjopen-2024-091381. |
| FG001 | Frozen Plasma | Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing >60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if >60 kg). Frozen Plasma Product, Human |
| Per-protocol Population (PP) |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Octaplex | Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing >60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if >60 kg). Octaplex: Prothrombin complex concentrate |
| BG001 | Frozen Plasma | Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing >60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if >60 kg). Frozen Plasma Product, Human |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Height | Mean | Standard Deviation | centimeter (cm) |
| |||||||||||||||
| Body Weight | Mean | Standard Deviation | kilogram (kg) |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m²) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Requiring Additional Hemostatic Intervention | Defined as 'effective' if no additional hemostatic intervention, such as administration of any systemic hemostatic agents (including platelets, cryoprecipitate, fibrinogen concentrate, activated recombinant factor VII [rFVIIa], other coagulation factor products or a second dose of IMP) or any hemostatic interventions (including surgical re-opening for bleeding) is required from 60 minutes to 24 hours after initiation of the first dose of IMP. | Posted | Count of Participants | Participants | 60 minutes to 24 hours after first dose of IMP |
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| Secondary | Comparison of Global Hemostatic Response Based on Requirement of Additional Hemostatic Intervention and Decreased Hemoglobin Levels | Defined as 'positive' if no additional hemostatic intervention is required and hemoglobin levels decrease by <30% (after accounting for red cell transfusions) from 60 minutes to 24 hours after initiation of the first dose of IMP. | Data were not available for 2 patients in the FP group due to missing hemoglobin values. | Posted | Count of Participants | Participants | 60 minutes to 24 hours after first dose of IMP |
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| Secondary | Compare the Amount of Chest Tube Drainage Between the Octaplex and FP Groups. | Posted | Mean | Standard Deviation | Milliliters (mL) | 12 and 24 hours after chest closure |
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| Secondary | Compare the Incidence of Severe to Massive Bleeding Between the Octaplex and FP Groups Using a Modification of the Universal Definition of Perioperative Bleeding (UDPB). | Yes or no refers to whether severe to massive bleeding was present. | Posted | Count of Participants | Participants | 24 hours after surgery start, after the end of CPB and after IMP initiation |
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| Secondary | Compare Efficacy in Terms of the Mean Number of Total Allogeneic Blood Products (ABPs) (IMP and Non-IMP) Transfused Between the Octaplex and FP Groups. | Posted | Mean | Standard Deviation | total ABPs | First 24 hours after the end of CPB |
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| Secondary | Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Products Transfused Between the Octaplex and FP Groups. | Posted | Mean | Standard Deviation | total non-IMP ABPs | First 24 hours after the end of CPB |
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| Secondary | Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. | Posted | Mean | Standard Deviation | Total non-IMP ABPs | First 24 hours and 7 days after IMP initiation |
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| Secondary | Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. | Posted | Mean | Standard Deviation | ABPs | 24 hours and 7 days after start of surgery, and after the end of CPB and after IMP initiation |
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| Secondary | Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. | Posted | Count of Participants | Participants | 24 hours and 7 days after start of surgery and after the end of CPB and after IMP initiation |
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| Secondary | Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups | Posted | Count of Participants | Participants | 24 hours and 7 days after the start of surgery, after the end of CPB and after IMP initiation |
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| Secondary | Compare Incidence of Intracerebral Hemorrhage Between the Octaplex and FP Groups | Posted | Number | participants | 24 hours after start of surgery, after the end of CPB and after IMP initiation |
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| Secondary | Compare Incidence of Gastrointestinal Hemorrhage Between Octaplex and FP Groups | Posted | Number | participants | 24 hours after start of surgery, after the end of CPB and after IMP initiation |
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| Secondary | Compare Incidence of Surgical Re-exploration Between Octaplex and FP Groups | Posted | Count of Participants | Participants | 24 hours after start of surgery, after the end of CPB and after IMP initiation |
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| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in International Normalised Ratio (INR) Before and After Therapy Administration. | The international normalized ratio (INR) is a standardized measure of prothrombin time (PT), ensuring consistency in results across different laboratories. The normal range for INR is around 0.8 to 1.2. Higher INR values indicate a slower clotting time and are associated with bleeding. Effective procoagulant therapy can reduce/normalize the INR. INR reduction was considered successful if the magnitude of the reduction was >1.0 or the post-treatment level dropped below 1.5 (INR >1.5 indicates that one or more coagulation factor levels are below the 30% critical threshold) | The analysis of absolute change included all patients who had INR data available at both pre- and post-IMP time points. | Posted | Mean | Standard Deviation | international normalised ratio (INR) | Within 30 minutes before to 60 minutes after the initiation of IMP administration. |
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| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in Prothrombin Time (PT) | The prothrombin time (PT) measures the time it takes for clotting to occur, primarily assessing the extrinsic pathway of the coagulation cascade. Normal PT values range from 9 to 13 seconds. Higher PT values indicate a prolonged clotting time, suggesting potential issues with clotting factors such as fibrinogen, factors V, VII, and X and prothrombin, and are associated with bleeding. Effective procoagulant therapy can reduce/normalize the PT. | Posted | Mean | Standard Deviation | seconds | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in Activated Partial Thromboplastin Time (aPTT) | Activated partial thromboplastin time (aPTT) is a standard laboratory test that measures how long it takes (in seconds) for clotting to occur (in the presence of an activator). It evaluates the intrinsic and common pathways of the coagulation cascade, assessing factors such as VIII, IX, XI, and XII, as well as fibrinogen. Prolonged aPTT may signify deficiencies in these clotting factors and is associated with bleeding. Effective procoagulant therapy can shorten/normalize the aPTT. | Posted | Mean | Standard Deviation | seconds | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
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| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in Fibrinogen Activity | Posted | Mean | Standard Deviation | grams per liter (g/L) | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
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| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM EXTEM CT | A rotational thromboelastometry (ROTEM; Werfen) device can be used at the bedside to rapidly assess the patient's coagulation status. Different viscoelastic tests can be performed to assess the dynamics of clot formation and lysis. Specifically, the EXTEM test is activated with tissue factor and evaluates the extrinsic coagulation pathway, with clotting time (CT) providing a measure (in seconds) of how quickly a clot starts forming. Prolonged EXTEM CT is associated with bleeding. Effective procoagulant therapy can reduce/normalize the EXTEM CT. | Few data were available as ROTEM measurements were not mandated by the study protocol. | Posted | Mean | Standard Deviation | seconds | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
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| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM EXTEM MCF | A rotational thromboelastometry (ROTEM; Werfen) device can be used at the bedside to rapidly assess the patient's coagulation status. Different viscoelastic tests can be performed to assess the dynamics of clot formation and lysis. Specifically, the EXTEM test is activated with tissue factor and evaluates the extrinsic coagulation pathway, with maximum clot firmness (MCF) providing a measure (in mm) of the strength of the clot. Reduced EXTEM MCF is associated with bleeding. Effective procoagulant therapy can increase/normalize the EXTEM MCF. | Few data were available as ROTEM measurements were not mandated by the study protocol. | Posted | Mean | Standard Deviation | Millimeters (mm) | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM FIBTEM MCF | A rotational thromboelastometry (ROTEM; Werfen) device can be used at the bedside to rapidly assess the patient's coagulation status. Different viscoelastic tests can be performed to assess the dynamics of clot formation and lysis. Specifically, the FIBTEM test evaluates fibrin-based clotting - it is extrinsically activated with tissue factor and additionally incorporates an inhibitor to eliminate the contribution of platelets to clotting. Maximum clot firmness (MCF) in the FIBTEM test provides a measure (in mm) of the strength of the fibrin-based clot. Reduced FIBTEM MCF is associated with bleeding. Effective procoagulant therapy to restore fibrinogen can increase/normalize the FIBTEM MCF. | Few data were available as ROTEM measurements were not mandated by the study protocol. | Posted | Mean | Standard Deviation | Millimeters (mm) | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in Platelet Count Measured by Plateletworks | The analysis of absolute change included all patients who had coagulation parameter data available at both pre- and post-IMP time points. | Posted | Mean | Standard Deviation | 10^9 platelets/L | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of the Effect of Octaplex Versus FP Administration on the Change in Platelet Function Measured by Plateletworks | The Plateletworks device (Helena Laboratories) enables rapid bedside screening of platelet function. The system uses an impedance cell counter and Plateletworks reagent tubes to evaluate platelet function and monitor treatment effects. By comparing a baseline total platelet count against the platelet count measured in the presence of an agonist used to stimulate platelet aggregation (ADP, collagen, or arachidonic acid), the tests determine the percent aggregation or inhibition of functional platelets. Manufacturer reference ranges, determined by testing blood samples from healthy volunteers, are 86-100% for ADP, 70-100% for collagen, and 60-100% for arachidonic acid. Values within these ranges indicate 'normal (positive)' platelet aggregation, which is important for clotting; lower values may be considered 'abnormal (negative)' and reflective of platelet inhibition. The manufacturer advises each laboratory to establish their own reference ranges for their patient population. | The analysis of absolute change included all patients who had coagulation parameter data available at both pre- and post-IMP time points. | Posted | Mean | Standard Deviation | percentage | Within 75 minutes before to within 75 minutes after the initiation of IMP administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of Total Time Elapsed From Initiation of the First Dose of IMP to Arrival Into the ICU Between the Octaplex and FP Groups. | 37 patients were excluded from the analysis population. 27 (12 in the Octaplex group, 25 in the FP group) who were already in the ICU when the first dose of IMP was initiated, 5 patients (2 in the Octaplex group, 3 in the FP group) for whom the time intervals could not be calculated due to incomplete date/time of arrival at ICU, and 1 patient (FP group) who was not in the ICU, therefore the time interval could not be calculated. | Posted | Median | Inter-Quartile Range | hours | From initiation of IMP to arrival at ICU room (within 24 hours) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of Incidence of Serious Treatment-emergent Adverse Events Between Octaplex and FP Groups | Posted | Count of Participants | Participants | From the beginning of surgery up to postoperative day 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of the Duration of Mechanical Ventilation Between Octaplex and FP Groups | Posted | Median | Inter-Quartile Range | days | From the beginning of surgery up to postoperative day 30 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of the Duration of ICU Stay Between Octaplex and FP Groups | Three patients in the FP group were excluded from this analysis due to missing dates of ICU stays | Posted | Median | Inter-Quartile Range | days | From the beginning of surgery up to postoperative day 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of the Duration of Hospitalization Between Octaplex and FP Groups | One patient in the FP group was excluded from analysis due to missing data | Posted | Median | Inter-Quartile Range | days | From the beginning of surgery up to postoperative day 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of the Incidence of Death Between Octaplex and FP Groups | Posted | Count of Participants | Participants | Up to 30 days after the end of CPB |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of the Number of Days Alive and Out of Hospital Between Octaplex and FP Groups | One participant is excluded from analysis due to missing start/end date of hospitalization. | Posted | Median | Inter-Quartile Range | days | From the beginning of surgery up to postoperative day 30 |
|
From beginning of surgery to 30 days after surgery start
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Octaplex | Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing >60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if >60 kg). Octaplex: Prothrombin complex concentrate | 7 | 213 | 77 | 213 | 206 | 213 |
| EG001 | Frozen Plasma | Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing >60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if >60 kg). Frozen Plasma Product, Human | 8 | 207 | 98 | 207 | 201 | 207 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal abscess | Infections and infestations | Systematic Assessment |
| ||
| Endocarditis | Infections and infestations | Systematic Assessment |
| ||
| Gall bladder abscess | Infections and infestations | Systematic Assessment |
| ||
| Gangrene | Infections and infestations | Systematic Assessment |
| ||
| Graft infection | Infections and infestations | Systematic Assessment |
| ||
| Klebsiella bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Mediastinitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia aspiration | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia bacterial | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia escherichia | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia klebsiella | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia pseudomonal | Infections and infestations | Systematic Assessment |
| ||
| Post procedural pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Post procedural sepsis | Infections and infestations | Systematic Assessment |
| ||
| Prosthetic valve endocarditis | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Staphylococcal bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Stenotrophomonas bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Stenotrophomonas maltophilia pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection pseudomonal | Infections and infestations | Systematic Assessment |
| ||
| Wound infection | Infections and infestations | Systematic Assessment |
| ||
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Splenic infarction | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anaphylactic shock | Immune system disorders | Systematic Assessment |
| ||
| Adrenal insufficiency | Endocrine disorders | Systematic Assessment |
| ||
| Diabetic ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypervolemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Altered state of consciousness | Nervous system disorders | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Embolic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Generalised tonic-clonic seizure | Nervous system disorders | Systematic Assessment |
| ||
| Ischemic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Metabolic encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Acute right ventricular failure | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Atrioventricular block complete | Cardiac disorders | Systematic Assessment |
| ||
| Atrioventricular block second degree | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac tamponade | Cardiac disorders | Systematic Assessment |
| ||
| Cardio-respiratory arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
| ||
| Carditis | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery occlusion | Cardiac disorders | Systematic Assessment |
| ||
| Dressler's syndrome | Cardiac disorders | Systematic Assessment |
| ||
| Intrapericardial thrombosis | Cardiac disorders | Systematic Assessment |
| ||
| Low cardiac output syndrome | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Nodal arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Nodal rhythm | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
| ||
| Pericarditis | Cardiac disorders | Systematic Assessment |
| ||
| Pulseless electrical activity | Cardiac disorders | Systematic Assessment |
| ||
| Right ventricular dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Right ventricular failure | Cardiac disorders | Systematic Assessment |
| ||
| Sinus node dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Aortic thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Arterial hemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Distributive shock | Vascular disorders | Systematic Assessment |
| ||
| Extremity necrosis | Vascular disorders | Systematic Assessment |
| ||
| Hemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Jugular vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Obstructive shock | Vascular disorders | Systematic Assessment |
| ||
| Peripheral artery thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Peripheral ischemia | Vascular disorders | Systematic Assessment |
| ||
| Shock | Vascular disorders | Systematic Assessment |
| ||
| Shock hemorrhagic | Vascular disorders | Systematic Assessment |
| ||
| Subclavian vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Superficial vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Venous hemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lung opacity | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Mediastinal hematoma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Mediastinal hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary necrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Thoracic hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Abdominal compartment syndrome | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal ischemia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hepatic failure | Hepatobiliary disorders | Systematic Assessment |
| ||
| Ischemic hepatitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Liver injury | Hepatobiliary disorders | Systematic Assessment |
| ||
| Skin discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal tubular necrosis | Renal and urinary disorders | Systematic Assessment |
| ||
| Scrotum erosion | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Catheter site thrombosis | General disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment | The cause of death of the participant was unknown. The SAE 'death' had the reported AE term 'Death not otherwise specified (NOS)'. |
| |
| Generalised edema | General disorders | Systematic Assessment |
| ||
| Multiple organ dysfunction syndrome | General disorders | Systematic Assessment |
| ||
| Edema peripheral | General disorders | Systematic Assessment |
| ||
| Prosthetic cardiac valve thrombosis | General disorders | Systematic Assessment |
| ||
| Vessel puncture site thrombosis | General disorders | Systematic Assessment |
| ||
| Anticoagulation drug level above therapeutic | Investigations | Systematic Assessment |
| ||
| Hepatic enzyme increased | Investigations | Systematic Assessment |
| ||
| Complications of transplanted kidney | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Dilutional coagulopathy | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Graft hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Head injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post procedural hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Postpericardiotomy syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural shock | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Sternal fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Transfusion-related circulatory overload | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Traumatic hemothorax | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular graft thrombosis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vasoplegia syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Venous injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Device pacing issue | Product Issues | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile infection | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Localised infection | Infections and infestations | Systematic Assessment |
| ||
| Oral candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia klebsiella | Infections and infestations | Systematic Assessment |
| ||
| Postoperative wound infection | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection bacterial | Infections and infestations | Systematic Assessment |
| ||
| Wound infection | Infections and infestations | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Splenic infarction | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Alkalosis hypochloremic | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypervolemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypovolemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Lactic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Confusional state | Psychiatric disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Hallucination, visual | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Altered state of consciousness | Nervous system disorders | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Cognitive disorder | Nervous system disorders | Systematic Assessment |
| ||
| Generalised tonic-clonic seizure | Nervous system disorders | Systematic Assessment |
| ||
| ICU acquired weakness | Nervous system disorders | Systematic Assessment |
| ||
| Migraine | Nervous system disorders | Systematic Assessment |
| ||
| Nystagmus | Nervous system disorders | Systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Accelerated idioventricular rhythm | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Atrioventricular block | Cardiac disorders | Systematic Assessment |
| ||
| Atrioventricular block complete | Cardiac disorders | Systematic Assessment |
| ||
| Atrioventricular block first degree | Cardiac disorders | Systematic Assessment |
| ||
| Atrioventricular block second degree | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Bundle branch block left | Cardiac disorders | Systematic Assessment |
| ||
| Bundle branch block right | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac tamponade | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
| ||
| Dressler's syndrome | Cardiac disorders | Systematic Assessment |
| ||
| Nodal arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Nodal rhythm | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
| ||
| Pericarditis | Cardiac disorders | Systematic Assessment |
| ||
| Pulseless electrical activity | Cardiac disorders | Systematic Assessment |
| ||
| Right ventricular dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Right ventricular failure | Cardiac disorders | Systematic Assessment |
| ||
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Sinus node dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Supraventricular extrasystoles | Cardiac disorders | Systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular extrasystoles | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Distributive shock | Vascular disorders | Systematic Assessment |
| ||
| Extremity necrosis | Vascular disorders | Systematic Assessment |
| ||
| Hematoma | Vascular disorders | Systematic Assessment |
| ||
| Hemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Peripheral ischemia | Vascular disorders | Systematic Assessment |
| ||
| Phlebitis | Vascular disorders | Systematic Assessment |
| ||
| Shock | Vascular disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rales | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhonchi | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Tachypnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Thoracic hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal ischemia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hepatic failure | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatic function abnormal | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hypertransaminasemia | Hepatobiliary disorders | Systematic Assessment |
| ||
| Ischemic hepatitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Decubitus ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Oliguria | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Generalised edema | General disorders | Systematic Assessment |
| ||
| Multiple organ dysfunction syndrome | General disorders | Systematic Assessment |
| ||
| Edema | General disorders | Systematic Assessment |
| ||
| Edema peripheral | General disorders | Systematic Assessment |
| ||
| Prosthetic cardiac valve thrombosis | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
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| Blood creatinine increased | Investigations | Systematic Assessment |
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| Blood lactic acid increased | Investigations | Systematic Assessment |
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| Blood potassium decreased | Investigations | Systematic Assessment |
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| Breath sounds abnormal | Investigations | Systematic Assessment |
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| Chest X-ray abnormal | Investigations | Systematic Assessment |
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| Coagulation factor increased | Investigations | Systematic Assessment |
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| Ejection fraction decreased | Investigations | Systematic Assessment |
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| Hemoglobin decreased | Investigations | Systematic Assessment |
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| Heart rate increased | Investigations | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | Systematic Assessment |
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| INR increased | Investigations | Systematic Assessment |
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| Liver function test increased | Investigations | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Troponin increased | Investigations | Systematic Assessment |
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| Urine output decreased | Investigations | Systematic Assessment |
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| Venous oxygen saturation decreased | Investigations | Systematic Assessment |
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| White blood cell count increased | Investigations | Systematic Assessment |
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| Anemia postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post procedural hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Postoperative delirium | Injury, poisoning and procedural complications | Systematic Assessment |
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| Postoperative ileus | Injury, poisoning and procedural complications | Systematic Assessment |
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| Postpericardiotomy syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vasoplegia syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
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| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Keyvan Karkouti | Toronto General Hospital | (416) 340-8597 | keyvan.karkouti@uhn.ca |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 28, 2024 | Jun 27, 2025 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| C025667 | prothrombin complex concentrates |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing >60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if >60 kg). Frozen Plasma Product, Human |
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| Participants |
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| OG001 | Frozen Plasma | Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing >60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if >60 kg). Frozen Plasma Product, Human: If additional coagulation factor replacement therapy was required after the maximum dose of IMP was administered or the 24-hour treatment period had elapsed, patients in both groups received frozen plasma. |
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| Units | Counts |
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| Participants |
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| OG001 | Frozen Plasma | Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing >60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if >60 kg). Frozen Plasma Product, Human |
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