Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Grifols Biologicals, LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to test whether the administration of ATIII during the intra-operative period results in improved anticoagulation for cardiopulmonary bypass (CPB) and an attenuation of the activation of the coagulation cascade, as represented by a decrease in fibrin degradation products. The investigators believe this benefit would extend into the post-operative period resulting in a decreased incidence of thrombosis generation, as represented by a decrease in fibrin degradation products in the ICU period.
If Preoperative ATIII functional assay level is less than 70% patients would be enrolled and randomized to either Placebo (normal saline) or ATIII.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-thrombin III | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-thrombin III | Drug | Intraoperatively- (correcting to 100%) according to the following formula: Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Time 5 (on Arrival in ICU) | Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) measurements of the control and ATIII groups at Time 5 (on arrival in ICU). | Time 5 (on arrival in ICU) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Mean and SD of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Times 5-Time 7 (ICU Arrival to Post Operative Day 4) | Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean and SD of the Calibrated Automated Thrombography (CAT) measurements of the control and ATIII groups at times 5-Time 7 (ICU arrival to Post Operative Day 4) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Edmund Jooste, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27708 | United States |
Not provided
Five subjects enrolled but withdrew prior to randomization
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Anti-thrombin III | Intraoperatively- (correcting to 100%) according to the following formula: Units required = ((100%- baseline ATIII level*%) X body weight)/1.4 * expressed as a % normal level based on functional ATIII assay |
| FG001 | Placebo | Normal saline placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Anti-thrombin III | Intraoperatively- (correcting to 100%) according to the following formula: Units required = ((100%- baseline ATIII level*%) X body weight)/1.4 * expressed as a % normal level based on functional ATIII assay |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Difference in the Mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Time 5 (on Arrival in ICU) | Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) measurements of the control and ATIII groups at Time 5 (on arrival in ICU). | The laboratory was unable to perform this blood assay due to technical issues and no results were generated. | Posted | Time 5 (on arrival in ICU) |
|
Adverse events were collected from Baseline (intraoperatively) until post-operative day four.
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 | Anti-thrombin III | Intraoperatively- (correcting to 100%) according to the following formula: Units required = ((100%- baseline ATIII level*%) X body weight)/1.4 * expressed as a % normal level based on functional ATIII assay |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension R/T chest fluid retention (not bleeding) | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Junctional ectopic tachycardia | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Edmund Jooste | Duke University | 919-681-4877 | edmund.jooste@duke.edu |
Not provided
| ID | Term |
|---|---|
| D000990 | Antithrombin III |
| ID | Term |
|---|---|
| D058833 | Antithrombin Proteins |
| D015843 | Serpins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Other | Normal saline placebo |
|
| ICU arrival (Time 5) to Time 7 (Post-operative Day 4) |
| Difference in the Mean the ATIII (Functional Assay) of the Control and ATIII Groups at T1, T2, T3, T5, T6 and T7 | Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean of the ATIII (functional assay) of the control and ATIII groups at T1, T2, T3, T5, T6 and T7 (Baseline, 30 min after study drug, 30 min on CPB, Arrival in ICU, POD 2, and POD 4). Data reported as % Functional Activity, which is calculated as the ability of Antithrombin (AT) to suppress FIIa or FXa in the presence of heparin compared to normograms, and expressed as a percentage. | T1, T2, T3, T5, T6 and T7 |
| Difference in the Median of the ATIII (Functional Assay) of the Control and ATIII Groups at T4 | Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the median of the ATIII (functional assay) of the control and ATIII groups at T4 (just prior to coming off of CPB). Data reported as % Functional Activity, which is calculated as the ability of Antithrombin (AT) to suppress FIIa or FXa in the presence of heparin compared to normograms, and expressed as a percentage. | T4 (just prior to coming off of CPB) |
| Difference in the Median of the D Dimer of the Control and ATIII Groups at T1, T5, T6 and T7 | Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the median of the D dimer of the control and ATIII groups at T1 (Baseline), T5 (Arrival in Intensive Care Unit), T6 (Post-Operative Day 2) and T7 (Post-Operative Day 4). | T1, T5, T6 and T7 |
| Residual Heparin at the ICU Arrival Time Point Represented by a Decreased Anti Factor Xa Level. | Evidence of a decreased amount of residual heparin at the Intensive Care Unit arrival time point (T5) represented by a decreased anti factor Xa level. | T5 (Intensive Care Unit Arrival) |
| Evidence of Decreased Inflammation Represented by a Decrease in Inflammatory Markers in the ATIII Group | Evidence of decreased inflammation represented by a decrease in inflammatory markers in the ATIII group. | Baseline (T1) to Post-Operative Day 4 (T7) |
| Total Dose of Heparin While on Cardiopulmonary Bypass | Total dose of Heparin while on Cardiopulmonary Bypass | T1 (Baseline) to T5 (Arrival in ICU) |
| Protamine Dose Determined by Hemostasis Management System Machine (mg/kg) | Protamine dose determined by Hemostasis Management system machine (mg/kg) | T1 (Baseline) to T5 (Arrival in ICU) |
| Total Volume of Blood Products While on CPB | Total volume of blood products exposed intraoperatively including the pump prime (ml/kg) | Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4) |
| Time From Protamine Administration to Skin Dressing | Time from protamine administration to skin dressing | Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4) |
| Total Volume of Fresh Frozen Plasma Given Prior to CPB | Total volume of Fresh Frozen Plasma given prior to CPB, including the pump prime (ml/kg) | Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4) |
| Incidence of Recombinant Factor 7a (VIIa) Use Intraoperatively | Incidence of Recombinant Factor 7a (VIIa) Use Intraoperatively | Baseline (Intraoperatively) |
| Volume of Postoperative Blood Loss | Volume of postoperative blood loss from 10min post protamine administration to 24 hour post protamine administration- (ml/kg) | From 10min post protamine administration to 24 hour post protamine administration |
| Chest Tube Output (Protamine Time Plus 24 Hours) in Milliliters | Chest Tube output (protamine time plus 24 hours) in milliliters | protamine time plus 24 hours |
| Number of Total Blood Product Units Transfused by Type 24-hours Post-operatively by Group | Number of packed Fresh frozen plasma units, Platelet Units, cryo-precipitate units, and Red Blood Cell units transfused 24 hours post-operatively for each group (not total units transfused for each subject) | 24 Hours Post-Operatively |
| Number of Total Blood Product Units Transfused 24-hours Post-operatively by Group | Number of total blood product units (including packed Fresh frozen plasma units, Platelet Units, cryo-precipitate units, and Red Blood Cell units) transfused 24 hours post-operatively for each group (not total units transfused for each subject) | 24 Hours Post-Operatively |
| Total Dose of Recombinant Factor 7a (VIIa) Used Intraoperatively | Total Dose of rescue recombinant factor 7a (VIIa) used intraoperatively | Intraoperatively |
| Length of Post Operative Ventilation in Days | Length of post operative ventilation in days | ICU arrival (Time 5) to Time 7 (Post-Operative Day 4) |
| Incidence of Extracorporeal Membrane Oxygenation (ECMO) Support Within 24 Hours Postoperatively | Study the safety profile of dosing the ATIII by monitoring the incidence of extracorporeal membrane oxygenation (ECMO) support within 24 hours postoperatively. | Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4) |
| Incidence of Mediastinal Exploration Within 24 Hours Postoperatively | Study the safety profile of dosing the ATIII by monitoring the incidence of mediastinal exploration within 24 hours postoperatively | Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4) |
| Incidence (Number) of Thrombotic Events Documented | Study the safety profile of dosing the ATIII by monitoring the incidence (number) of thrombotic events documented. | Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4) |
| Incidence of New Onset Renal Failure, Defined by Stage 3 of the AKIN Criteria | Study the safety profile of dosing the ATIII by monitoring the incidence of new onset renal failure, defined by stage 3 of the Acute Kidney Injury Network (AKIN) criteria.
| Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4) |
| Incidence (Number) of Newly Diagnosed Intracranial Hemorrhage | Study the safety profile of dosing the ATIII by monitoring the incidence (number) of newly diagnosed intracranial hemorrhage | Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4) |
| Length of Time to Delayed Sternal Closure Measured in Days | Study the safety profile of dosing the ATIII by monitoring the length of time to delayed sternal closure measured in days | Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4) |
Placebo: Normal saline placebo |
| BG002 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo |
Normal saline placebo |
|
| Secondary | Difference in the Mean and SD of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Times 5-Time 7 (ICU Arrival to Post Operative Day 4) | Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean and SD of the Calibrated Automated Thrombography (CAT) measurements of the control and ATIII groups at times 5-Time 7 (ICU arrival to Post Operative Day 4) | The laboratory was unable to perform this blood assay due to technical difficulties and no results were generated. | Posted | ICU arrival (Time 5) to Time 7 (Post-operative Day 4) |
|
|
| Secondary | Difference in the Mean the ATIII (Functional Assay) of the Control and ATIII Groups at T1, T2, T3, T5, T6 and T7 | Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean of the ATIII (functional assay) of the control and ATIII groups at T1, T2, T3, T5, T6 and T7 (Baseline, 30 min after study drug, 30 min on CPB, Arrival in ICU, POD 2, and POD 4). Data reported as % Functional Activity, which is calculated as the ability of Antithrombin (AT) to suppress FIIa or FXa in the presence of heparin compared to normograms, and expressed as a percentage. | Posted | Mean | Standard Deviation | % Functional Activity | T1, T2, T3, T5, T6 and T7 |
|
|
|
|
| Secondary | Difference in the Median of the ATIII (Functional Assay) of the Control and ATIII Groups at T4 | Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the median of the ATIII (functional assay) of the control and ATIII groups at T4 (just prior to coming off of CPB). Data reported as % Functional Activity, which is calculated as the ability of Antithrombin (AT) to suppress FIIa or FXa in the presence of heparin compared to normograms, and expressed as a percentage. | Posted | Median | Inter-Quartile Range | % Functional Activity | T4 (just prior to coming off of CPB) |
|
|
|
|
| Secondary | Difference in the Median of the D Dimer of the Control and ATIII Groups at T1, T5, T6 and T7 | Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the median of the D dimer of the control and ATIII groups at T1 (Baseline), T5 (Arrival in Intensive Care Unit), T6 (Post-Operative Day 2) and T7 (Post-Operative Day 4). | Posted | Median | Inter-Quartile Range | mcg/ml | T1, T5, T6 and T7 |
|
|
|
|
| Secondary | Residual Heparin at the ICU Arrival Time Point Represented by a Decreased Anti Factor Xa Level. | Evidence of a decreased amount of residual heparin at the Intensive Care Unit arrival time point (T5) represented by a decreased anti factor Xa level. | In both arms, heparin level was undetectable as Anti factor Xa level was less than or equal to 0.1 IU/ml in all subjects. | Posted | Mean | Standard Deviation | International Units/milliter | T5 (Intensive Care Unit Arrival) |
|
|
|
| Secondary | Evidence of Decreased Inflammation Represented by a Decrease in Inflammatory Markers in the ATIII Group | Evidence of decreased inflammation represented by a decrease in inflammatory markers in the ATIII group. | Laboratory testing not performed. | Posted | Baseline (T1) to Post-Operative Day 4 (T7) |
|
|
| Secondary | Total Dose of Heparin While on Cardiopulmonary Bypass | Total dose of Heparin while on Cardiopulmonary Bypass | Posted | Median | Inter-Quartile Range | units | T1 (Baseline) to T5 (Arrival in ICU) |
|
|
|
|
| Secondary | Protamine Dose Determined by Hemostasis Management System Machine (mg/kg) | Protamine dose determined by Hemostasis Management system machine (mg/kg) | Posted | Median | Inter-Quartile Range | mg/kg | T1 (Baseline) to T5 (Arrival in ICU) |
|
|
|
|
| Secondary | Total Volume of Blood Products While on CPB | Total volume of blood products exposed intraoperatively including the pump prime (ml/kg) | Posted | Mean | Standard Deviation | mls | Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4) |
|
|
|
| Secondary | Time From Protamine Administration to Skin Dressing | Time from protamine administration to skin dressing | Posted | Median | Inter-Quartile Range | minutes | Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4) |
|
|
|
|
| Secondary | Total Volume of Fresh Frozen Plasma Given Prior to CPB | Total volume of Fresh Frozen Plasma given prior to CPB, including the pump prime (ml/kg) | Posted | Mean | Standard Deviation | ml/kg | Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4) |
|
|
|
| Secondary | Incidence of Recombinant Factor 7a (VIIa) Use Intraoperatively | Incidence of Recombinant Factor 7a (VIIa) Use Intraoperatively | Posted | Number | count of participants | Baseline (Intraoperatively) |
|
|
|
| Secondary | Volume of Postoperative Blood Loss | Volume of postoperative blood loss from 10min post protamine administration to 24 hour post protamine administration- (ml/kg) | Posted | Mean | Standard Deviation | ml/kg | From 10min post protamine administration to 24 hour post protamine administration |
|
|
|
|
| Secondary | Chest Tube Output (Protamine Time Plus 24 Hours) in Milliliters | Chest Tube output (protamine time plus 24 hours) in milliliters | Posted | Median | Inter-Quartile Range | milliters | protamine time plus 24 hours |
|
|
|
|
| Secondary | Number of Total Blood Product Units Transfused by Type 24-hours Post-operatively by Group | Number of packed Fresh frozen plasma units, Platelet Units, cryo-precipitate units, and Red Blood Cell units transfused 24 hours post-operatively for each group (not total units transfused for each subject) | Unable to be calculated accurately as blood products given in CPB prime were only designated in Units administered and not mls (no record of how many mls present in each unit). Therefore unable to back calculate total mls given from start of surgery to 24 hours postop | Posted | Number | Units | 24 Hours Post-Operatively |
|
|
|
| Secondary | Number of Total Blood Product Units Transfused 24-hours Post-operatively by Group | Number of total blood product units (including packed Fresh frozen plasma units, Platelet Units, cryo-precipitate units, and Red Blood Cell units) transfused 24 hours post-operatively for each group (not total units transfused for each subject) | Posted | Number | Units | 24 Hours Post-Operatively |
|
|
|
|
| Secondary | Total Dose of Recombinant Factor 7a (VIIa) Used Intraoperatively | Total Dose of rescue recombinant factor 7a (VIIa) used intraoperatively | Posted | Mean | Standard Deviation | mcg | Intraoperatively |
|
|
|
|
| Secondary | Length of Post Operative Ventilation in Days | Length of post operative ventilation in days | Posted | Mean | Standard Deviation | days | ICU arrival (Time 5) to Time 7 (Post-Operative Day 4) |
|
|
|
|
| Secondary | Incidence of Extracorporeal Membrane Oxygenation (ECMO) Support Within 24 Hours Postoperatively | Study the safety profile of dosing the ATIII by monitoring the incidence of extracorporeal membrane oxygenation (ECMO) support within 24 hours postoperatively. | Posted | Number | number | Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4) |
|
|
|
|
| Secondary | Incidence of Mediastinal Exploration Within 24 Hours Postoperatively | Study the safety profile of dosing the ATIII by monitoring the incidence of mediastinal exploration within 24 hours postoperatively | Posted | Number | count of participants | Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4) |
|
|
|
|
| Secondary | Incidence (Number) of Thrombotic Events Documented | Study the safety profile of dosing the ATIII by monitoring the incidence (number) of thrombotic events documented. | Posted | Number | events | Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4) |
|
|
|
| Secondary | Incidence of New Onset Renal Failure, Defined by Stage 3 of the AKIN Criteria | Study the safety profile of dosing the ATIII by monitoring the incidence of new onset renal failure, defined by stage 3 of the Acute Kidney Injury Network (AKIN) criteria.
| Posted | Number | count of participants | Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4) |
|
|
|
|
| Secondary | Incidence (Number) of Newly Diagnosed Intracranial Hemorrhage | Study the safety profile of dosing the ATIII by monitoring the incidence (number) of newly diagnosed intracranial hemorrhage | Posted | Number | participants | Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4) |
|
|
|
|
| Secondary | Length of Time to Delayed Sternal Closure Measured in Days | Study the safety profile of dosing the ATIII by monitoring the length of time to delayed sternal closure measured in days | Posted | Mean | Standard Deviation | days | Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4) |
|
|
|
|
| 3 |
| 20 |
| 3 |
| 20 |
| EG001 | Placebo | Normal saline placebo | 8 | 20 | 7 | 20 |
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
|
| Right-sided tonic clonic seizure | Nervous system disorders | Systematic Assessment |
|
| Hypotension R/T bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Shock | Blood and lymphatic system disorders | Systematic Assessment |
|
| Right-sided subdural hematoma | Nervous system disorders | Systematic Assessment |
|
| Hemorrhage | Surgical and medical procedures | Systematic Assessment |
|
| Bradycardia | Surgical and medical procedures | Systematic Assessment |
|
| Hypotension | Surgical and medical procedures | Systematic Assessment |
|
| ECMO | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Intraop Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Junctional rhythm tachycardia | Cardiac disorders | Systematic Assessment |
|
| Hematochezia | Gastrointestinal disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Low Hematocrit | Blood and lymphatic system disorders | Systematic Assessment |
|
| Desaturation | Blood and lymphatic system disorders | Systematic Assessment |
|
| Intermittent PVCs R/T Low K, Low Mg | Blood and lymphatic system disorders | Systematic Assessment |
|
| SVTs | Cardiac disorders | Systematic Assessment |
|
| Echogenic focus in occipital parietal region | Nervous system disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Hemoparitoneum | Blood and lymphatic system disorders | Systematic Assessment |
|
| Posterior subdural hematoma | Nervous system disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Right Lung Collapse | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D000510 |
| Alpha-Globulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D005916 | Globulins |
| D019774 | Blood Coagulation Factor Inhibitors |
| D001685 | Biological Factors |
| T3 (30 minutes on CPB) |
|
| T5 (Arrival in ICU) |
|
| T6 (POD 2) |
|
| T7 (POD 4) |
|
| Equivalence |
T2 (30 minutes after study drug) |
| t-test, 2 sided | 0.001 | Equivalence | T3 (30 minutes on CPB) |
| t-test, 2 sided | 0.003 | Equivalence | T5 (Arrival in ICU) |
| t-test, 2 sided | 0.840 | Equivalence | T6 (POD 2) |
| t-test, 2 sided | 0.475 | Equivalence | T7 (POD 4) |
| T6 (POD 2) |
|
| T7 (POD 4) |
|
| Equivalence |
T5 (Arrival in ICU) |
| Wilcoxon (Mann-Whitney) | 0.313 | Equivalence | T6 (POD 2) |
| Wilcoxon (Mann-Whitney) | 0.008 | Equivalence | T7 (POD 4) |
| Total volume ultrafiltration Platelet transfusion |
|
| Total volume Cryoprecipitate transfusion |
|
| 24 hour postop Cryoprecipitate exposures |
|
| 24 hour postop Red Blood Cell exposures |
|
| 0.0351 |
| Superiority or Other (legacy) |
| t-test, 2 sided | 24 hour postop Cryoprecipitate exposures | 0.073 | Superiority or Other (legacy) |
| t-test, 2 sided | 24 hour postop Red Blood Cell exposures | 0.0196 | Superiority or Other (legacy) |
| Cryo-Precipitate Units |
|
| Red Blood Cell Units |
|