Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Octapharma | INDUSTRY |
Not provided
Not provided
Not provided
The aim of the current pilot study proposal is to compare the use of the purified human fibrinogen concentrate (Fibryga®, Octapharma USA) to cryoprecipitate for the treatment of cardiopulmonary bypass (CPB)-associated bleeding in pediatric cardiac patients in whom fibrinogen supplementation is indicated.
The investigators' hypothesis is that fibrinogen concentrate will be as effective as cryoprecipitate in achieving adequate hemostasis after separation from CPB in pediatric cardiac surgery patients.
Study Design: this will be a single-center, prospective, randomized, active-control study in pediatric (24 months of age or younger) patients undergoing elective cardiac surgery with CPB (n=30) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). Informed consent will be obtained from a parent or a legal guardian prior to surgery and anesthesia. Once the need for fibrinogen supplementation is confirmed, study participants will be randomized into one of two treatment groups (n=15 in each group):
The results of this study will be used for publication as well as the first stage towards a significantly larger randomized multi-center trial (see below).
Based on the results of this pilot study the investigators plan to conduct a large multi-center, randomized active-control non-inferiority trial in the future, comparing the use of FC to cryoprecipitate in a much larger cohort of pediatric patients undergoing cardiac surgery with CPB. Ultimately, the results of this trial are likely to improve the care of pediatric cardiac surgical patients experiencing post-CPB bleeding, an under-studied yet high-risk patient population.
Once the need for fibrinogen supplementation is confirmed, study participants will be randomized into one of two treatment groups (n=15 in each group):
Data to be obtained:
Demographic/preoperative data: collected from the medical record
Intra-operative Data:
Postoperative Data
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrinogen Concentrate | Experimental | Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). |
|
| Cryoprecipitate | Active Comparator | . Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrinogen | Drug | Fibrinogen Concentrate (Human) Injection [Fibryga] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). |
| Measure | Description | Time Frame |
|---|---|---|
| A Composite of the Number of Any Allogeneic Blood Products (RBCs, Plasma, Platelets, Cryoprecipitate) Transfused From Administration of the Study Medication Until 48 Hours After Surgery | comparison between study groups of the number of allogeneic blood products transfused (RBC, plasma, platelets, cryoprecipitate) from immediately after the administration of the study drug (fibrinogen concentrate or cryoprecipitate) until 48 hours since admission to the ICU | from immediately after the administration of the fibrinogen concentrate or cryoprecipitate through the first 48 hours after admission to the ICU/post anesthesia care unit |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Post CPB Bleeding (in ml) Between the Study Groups | (intraoperatively = cell saver volume in ml; postoperatively = chest drain output in ml) | from administration of fibrinogen concentrate or cryoprecipitate until 48 hours after primary postoperative admission to the ICU |
| Comparison of the Number RBC Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Keita Ikeda, MD | UVA Anesthesiology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23571685 | Background | Hvas AM, Andreasen JB, Christiansen K, Ravn HB. Ex-vivo response to blood products and haemostatic agents after paediatric cardiac surgery. Blood Coagul Fibrinolysis. 2013 Sep;24(6):587-92. doi: 10.1097/MBC.0b013e32836029d2. | |
| 24951020 | Background | Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Camara L, Guimaraes VA, Jatene MB, Hajjar LA. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1647-55. doi: 10.1016/j.jtcvs.2014.04.029. Epub 2014 Apr 18. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Fibrinogen Concentrate | Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). Fibrinogen: Fibrinogen Concentrate (Human) Injection [Fibryga] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). |
| FG001 | Cryoprecipitate | . Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The data consists of a total of 31 cases. However, as CPB was not performed for one patient (ID #29; in the Fibrygagroup), therefore this patient was excluded.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fibrinogen Concentrate | Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). Fibrinogen: Fibrinogen Concentrate (Human) Injection [Fibryga] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | A Composite of the Number of Any Allogeneic Blood Products (RBCs, Plasma, Platelets, Cryoprecipitate) Transfused From Administration of the Study Medication Until 48 Hours After Surgery | comparison between study groups of the number of allogeneic blood products transfused (RBC, plasma, platelets, cryoprecipitate) from immediately after the administration of the study drug (fibrinogen concentrate or cryoprecipitate) until 48 hours since admission to the ICU | Posted | Mean | Full Range | allogeneic blood products | from immediately after the administration of the fibrinogen concentrate or cryoprecipitate through the first 48 hours after admission to the ICU/post anesthesia care unit |
|
Adverse event data were collected from the time of study drug administration through 30 days after surgery (the postoperative period).
All adverse events, including mortality, acute kidney injury, stroke, severe myocardial dysfunction or myocardial infarction, and sepsis, were monitored from the day of study drug administration until 30 days postoperatively or hospital discharge, whichever occurred later.
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 | Fibrinogen Concentrate | Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). Fibrinogen: Fibrinogen Concentrate (Human) Injection [Fibryga] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure/Stroke | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacob Raphael | Thomas Jefferson University | 215-955-6161 | jacob.raphael@jefferson.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2020 | Oct 13, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 7, 2021 | Oct 13, 2025 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005340 | Fibrinogen |
| D007267 | Injections |
| C026912 | cryoprecipitate coagulum |
| ID | Term |
|---|---|
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Cryoprecipitate | Drug | Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). |
|
Comparison between the study groups of the number of RBC units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7 |
| From immediately after study medication administration through postoperative day 7 |
| Comparison of the Number Platelets Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7 | Comparison between the study groups of the number of platelets units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7 | From immediately after study medication administration through postoperative day 7 |
| Comparison of the Number Plasma Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7 | Comparison between the study groups of the number of plasma units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7 | From immediately after study medication administration through postoperative day 7 |
| Comparison of Additional Number Cryoprecipitate Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7 | Comparison between the study groups of the number of additional cryoprecipitate units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7 | From immediately after study medication administration through postoperative day 7 |
| Number of Participants With Postoperative Surgical Chest Re-exploration for Excessive Bleeding/Cardiac Tamponade | Comparison between study groups of the number of participants with postoperative surgical chest re-exploration in the ICU/OR for excessive bleeding or cardiac tamponade | from admission to the ICU until postoperative day 7 |
| Incidence of the Use of Factor VIIa for Bleeding | comparison of percent of patients requiring factor VIIa for bleeding (intraoperatively or postoperatively in the ICU between the study groups | from separation from CPB until 48 hours after surgery |
| In-hospital Mortality | comparison of the incidence of in-hospital mortality between the study groups | from admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier) |
| Post Operative Acute Kidney Injury (AKI) | comparison of the incidence of postoperative AKI between study groups. AKI will be assessed based on the Acute Kidney Injury Network (AKIN) classification (stages 0-3, with higher stage reflecting worse outcome) | from admission to the ICU until postoperative day 7 |
| Postoperative Infection | comparison of the incidence of pneumonia, sternal wound infection, mediastinitis, sepsis between study groups | rom admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier) |
| Percent of Patients With Postoperative Neurological Injury | Comparison between study groups of the percent of patients with seizures/stroke that occur after surgery | from admission to the ICU until POD 7 |
| Intubation Time | comparison of the time to intubation from the completion of surgery until extubation in the ICU between the study groups | from admission to the ICU until 30 days after surgery or discharge from the ICU (whichever is earlier) |
| Postoperative Thromboembolic Event | comparison of the incidence of DVT/PE/shunt thrombosis between the study groups | from admission to the ICU until 7 days postoperatively |
| ICU Length of Stay | comparison of the postoperative time period spent in the ICU | from admission to the ICU after surgery until 90 days after surgery or discharge from the ICU (whichever occurs earlier) |
| Hospital Length of Stay | comparison between the study groups of the time in the hospital from admission to the ICU postoperatively until discharge from the hospital | from admission to the ICU postoperatively until postoperative day 90 or discharge from the hospital (whichever occurs earlier) |
| 25982134 | Background | Haas T, Spielmann N, Restin T, Seifert B, Henze G, Obwegeser J, Min K, Jeszenszky D, Weiss M, Schmugge M. Higher fibrinogen concentrations for reduction of transfusion requirements during major paediatric surgery: A prospective randomised controlled trial. Br J Anaesth. 2015 Aug;115(2):234-43. doi: 10.1093/bja/aev136. Epub 2015 May 15. |
| 29446989 | Background | Haas T, Cushing MM, Asmis LM. Comparison of the efficacy of two human fibrinogen concentrates to treat dilutional coagulopathy in vitro. Scand J Clin Lab Invest. 2018 May;78(3):230-235. doi: 10.1080/00365513.2018.1437645. Epub 2018 Feb 15. |
| 26037084 | Background | Ranucci M, Baryshnikova E, Crapelli GB, Rahe-Meyer N, Menicanti L, Frigiola A; Surgical Clinical Outcome REsearch (SCORE) Group. Randomized, double-blinded, placebo-controlled trial of fibrinogen concentrate supplementation after complex cardiac surgery. J Am Heart Assoc. 2015 Jun 2;4(6):e002066. doi: 10.1161/JAHA.115.002066. |
| 25324348 | Background | Fassl J, Lurati Buse G, Filipovic M, Reuthebuch O, Hampl K, Seeberger MD, Bolliger D. Perioperative administration of fibrinogen does not increase adverse cardiac and thromboembolic events after cardiac surgery. Br J Anaesth. 2015 Feb;114(2):225-34. doi: 10.1093/bja/aeu364. Epub 2014 Oct 16. |
| No evidence of hypofibrinogenemia |
|
| BG001 | Cryoprecipitate | . Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| OG001 | Cryoprecipitate | . Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). |
|
|
| Secondary | Comparison of Post CPB Bleeding (in ml) Between the Study Groups | (intraoperatively = cell saver volume in ml; postoperatively = chest drain output in ml) | Posted | Mean | Full Range | mL | from administration of fibrinogen concentrate or cryoprecipitate until 48 hours after primary postoperative admission to the ICU |
|
|
|
| Secondary | Comparison of the Number RBC Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7 | Comparison between the study groups of the number of RBC units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7 | Posted | Median | Inter-Quartile Range | RBC units | From immediately after study medication administration through postoperative day 7 |
|
|
|
| Secondary | Comparison of the Number Platelets Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7 | Comparison between the study groups of the number of platelets units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7 | Posted | Median | Inter-Quartile Range | platelets units | From immediately after study medication administration through postoperative day 7 |
|
|
|
| Secondary | Comparison of the Number Plasma Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7 | Comparison between the study groups of the number of plasma units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7 | Posted | Median | Inter-Quartile Range | plasma units | From immediately after study medication administration through postoperative day 7 |
|
|
|
| Secondary | Comparison of Additional Number Cryoprecipitate Units Transfused Immediately After Administration of the Study Medication and Until Postoperative Day 7 | Comparison between the study groups of the number of additional cryoprecipitate units transfused immediately after administration of the study medication (fibrinogen concentrate or cryoprecipitate) until postoperative day 7 | Posted | Median | Inter-Quartile Range | additional cryoprecipitate units | From immediately after study medication administration through postoperative day 7 |
|
|
|
| Secondary | Number of Participants With Postoperative Surgical Chest Re-exploration for Excessive Bleeding/Cardiac Tamponade | Comparison between study groups of the number of participants with postoperative surgical chest re-exploration in the ICU/OR for excessive bleeding or cardiac tamponade | Posted | Count of Participants | Participants | from admission to the ICU until postoperative day 7 |
|
|
|
| Secondary | Incidence of the Use of Factor VIIa for Bleeding | comparison of percent of patients requiring factor VIIa for bleeding (intraoperatively or postoperatively in the ICU between the study groups | Posted | Count of Participants | Participants | from separation from CPB until 48 hours after surgery |
|
|
|
| Secondary | In-hospital Mortality | comparison of the incidence of in-hospital mortality between the study groups | Posted | Count of Participants | Participants | from admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier) |
|
|
|
| Secondary | Post Operative Acute Kidney Injury (AKI) | comparison of the incidence of postoperative AKI between study groups. AKI will be assessed based on the Acute Kidney Injury Network (AKIN) classification (stages 0-3, with higher stage reflecting worse outcome) | Posted | Count of Participants | Participants | from admission to the ICU until postoperative day 7 |
|
|
|
| Secondary | Postoperative Infection | comparison of the incidence of pneumonia, sternal wound infection, mediastinitis, sepsis between study groups | Posted | Count of Participants | Participants | rom admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier) |
|
|
|
| Secondary | Percent of Patients With Postoperative Neurological Injury | Comparison between study groups of the percent of patients with seizures/stroke that occur after surgery | Posted | Count of Participants | Participants | from admission to the ICU until POD 7 |
|
|
|
| Secondary | Intubation Time | comparison of the time to intubation from the completion of surgery until extubation in the ICU between the study groups | Protocol was amended (as of 3-30-2020 prior to first enrollment on 10-27-2021) to not assess this Secondary Outcome Measure. Thus, no data on intubation time was collected. | Posted | Number | from admission to the ICU until 30 days after surgery or discharge from the ICU (whichever is earlier) |
|
|
|
| Secondary | Postoperative Thromboembolic Event | comparison of the incidence of DVT/PE/shunt thrombosis between the study groups | Posted | Count of Participants | Participants | from admission to the ICU until 7 days postoperatively |
|
|
|
| Secondary | ICU Length of Stay | comparison of the postoperative time period spent in the ICU | Posted | Mean | Standard Deviation | days | from admission to the ICU after surgery until 90 days after surgery or discharge from the ICU (whichever occurs earlier) |
|
|
|
| Secondary | Hospital Length of Stay | comparison between the study groups of the time in the hospital from admission to the ICU postoperatively until discharge from the hospital | Posted | Mean | Standard Deviation | days | from admission to the ICU postoperatively until postoperative day 90 or discharge from the hospital (whichever occurs earlier) |
|
|
|
| 0 |
| 11 |
| 1 |
| 11 |
| 0 |
| 11 |
| EG001 | Cryoprecipitate | . Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). Cryoprecipitate: Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). | 0 | 15 | 0 | 15 | 3 | 15 |
| Cardioversion | Cardiac disorders | Systematic Assessment |
|
| Internal Chest Compressions and Pacing | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001779 |
| Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |