Cardiac Surgery, Coagulopathy, Liver Dysfunction, Liver Surgery
Conditions
Keywords
Pediatric, patients, replacement, coagulation factors, plasma, s/d plasma, Octaplas, plasma replacement
Brief summary
The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas in pediatric patients who require replacement of multiple coagulation factors. Replacement of multiple coagulation factors in pediatric patients with acquired deficiencies due to liver disease and/or in pediatric patients requiring cardiac surgery or liver surgery.
Interventions
BIOLOGICALoctaplas
Octaplas S/D Plasma
Sponsors
Octapharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Patient requiring liver or cardiac surgery and/or patient with liver dysfunction associated with coagulopathy in whom replacement of multiple coagulation factors is required. 2. Voluntarily given, written and signed informed consent by the patient's legal representative(s) or guardian(s). Children deemed old enough by the Investigator/institution to understand the risks and benefits of the study should also be made aware of the risks/benefits of the study and provide written assent. 3. Male or female patient ≤ 16 years of age.
Exclusion criteria
1. Patient with known homozygous congenital deficiency of protein S. 2. Patient has a history of hypersensitivity reaction to blood or plasma-derived products or to any excipient of the investigational product. 3. Patient has an already known IgA (Immunoglobulin A) deficiency with documented antibodies against IgA. 4. Patient has a congenital factor deficiency or platelet disorder requiring plasma treatment. 5. Patient is currently participating in another study investigating a new drug product or another interventional clinical study that may impact coagulation factors or has participated during the last three (3) months. 6. Patient received FFP (Fresh Frozen Plasma), FP24 (Plasma frozen within 24 hours of collection) or any other plasma product other than Octaplas within the last 72 hours (cryoprecipitate and albumin are not exclusionary) prior to first Octaplas infusion. 7. Patient is on ECMO (Extracorporeal Membrane Oxygenation) when plasma is ordered by the treating physician for the first infusion episode. 8. Patient is pregnant. 9. Patient is predicted to require massive blood transfusion defined as more than 40 mL per kilogram of all blood products in a 24-hour period 10. Patient is receiving plasma exchange, therapeutic plasma exchange (TPE) or plasmapheresis. 11. Patient is a premature neonate defined as less than 37 weeks gestation. 12. Cardiac surgery patients who develop the need for plasma replacement greater than 72 hours after the end of the associated cardiac surgery and do not have coagulopathy due to hepatic dysfunction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events) | up to 6 days | — |
| Monitoring of Clinically Significant Changes in White Blood Cells | up to 6 days | Assesses Pre- and Post-infusion for Infusion Episode 1 |
| Monitoring of Clinically Significant Changes in Red Blood Cells | up to 6 days | Assesses Pre- and Post-infusion for Infusion Episode 1 |
| Monitoring of Clinically Significant Changes in Hemoglobin | up to 6 days | Assesses Pre- and Post-infusion for Infusion Episode 1 |
| Monitoring of Clinically Significant Changes in Hematocrit | up to 6 days | Assesses Pre- and Post-infusion for Infusion Episode 1 |
| Monitoring of Clinically Significant Changes in Mean Corpuscular Volume (MCV) | up to 6 days | Assesses Pre- and Post-infusion for Infusion Episode 1 |
| Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH) | up to 6 days | Assesses Pre- and Post-infusion for Infusion Episode 1 |
| Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC) | up to 6 days | Assesses Pre- and Post-infusion for Infusion Episode 1 |
| Monitoring of Clinically Significant Changes in Red Cell Distribution Width (RDW) | up to 6 days | Assesses Pre- and Post-infusion for Infusion Episode 1 |
| Monitoring of Clinically Significant Changes in Platelets | up to 6 days | Assesses Pre- and Post-infusion for Infusion Episode 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medically Significant Changes in Oxygen Saturation | up to 6 days | — |
| Count of Investigator's Assessment of Overall Safety Observed for Patients by Category (Assessed to Have Overall Safety of 'Excellent', Assessed to Have Overall Safety of 'Moderate', Assessed to Have Overall Safety of 'Poor') | up to 6 days | — |
| Medically Significant Changes in Body Temperature | up to 6 days | — |
| Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient. | up to 6 days | Normal infusion: Replacement of multiple clotting factors Bypass priming: Limit hemodilution and reduce transfusion requirements Bypass warming up: Rewarm patients suffering from hypothermia during the surgery process |
| Medically Significant Changes in Blood Pressure | up to 6 days | — |
| Medically Significant Changes in Heart Rate | up to 6 days | — |
| Medically Significant Changes in Respiratory Rate | up to 6 days | — |
| Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR) | up to 6 days | This hemostatic parameter is figured out in the lab and helps to diagnose a bleeding disorder or excessive clotting disorder. The change of INR before and after 1st Octaplas infusion was scrutinized by analyzing the shifts between the classifications given below. |
| Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT) | up to 6 days | This hemostatic parameter is figured out in the lab and measures the time it takes for your blood to clot (the higher the PT the longer it takes your blood to clot). The change of PT before and after 1st Octaplas infusion was scrutinized by analyzing the shifts between the classifications given below. |
| Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM). | up to 6 days | TEG and ROTEM are methods of testing the efficiency of blood coagulation. The results were compared by looking at potential trends from TEG and ROTEM between pre-infusion vs post-infusion time points. |
| Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT) | up to 6 days | aPTT measures the length of time (in seconds) that it takes for clotting to occur in a test cube. The higher the number of seconds the longer it takes the blood to clot. The changes between pre - and post infusion were analyzed |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Octaplas Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Octaplas |
|---|---|
| ABO Blood Group A | 16 Participants |
| ABO Blood Group AB | 4 Participants |
| ABO Blood Group B | 9 Participants |
| ABO Blood Group O | 21 Participants |
| Age, Categorical <=18 years | 50 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 2.0 years STANDARD_DEVIATION 3.98 |
| BMI | 16.88 kg/m^2 STANDARD_DEVIATION 5.421 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 78.1 centimeters STANDARD_DEVIATION 30.49 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 26 Participants |
| Weight | 13.66 kilograms STANDARD_DEVIATION 21.589 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 5 / 50 |
Outcome results
Primary
Monitoring of Clinically Significant Changes in Hematocrit
Assesses Pre- and Post-infusion for Infusion Episode 1
Time frame: up to 6 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Octaplas | Monitoring of Clinically Significant Changes in Hematocrit | -2.35 volume percentage of RBC in blood |
| Infants ≤2 Years | Monitoring of Clinically Significant Changes in Hematocrit | 1.35 volume percentage of RBC in blood |
Primary
Monitoring of Clinically Significant Changes in Hemoglobin
Assesses Pre- and Post-infusion for Infusion Episode 1
Time frame: up to 6 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Octaplas | Monitoring of Clinically Significant Changes in Hemoglobin | -0.70 g/dL |
| Infants ≤2 Years | Monitoring of Clinically Significant Changes in Hemoglobin | 0.80 g/dL |
Primary
Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC)
Assesses Pre- and Post-infusion for Infusion Episode 1
Time frame: up to 6 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Octaplas | Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC) | -0.15 g/dL |
| Infants ≤2 Years | Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC) | 0.20 g/dL |
Primary
Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH)
Assesses Pre- and Post-infusion for Infusion Episode 1
Time frame: up to 6 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Octaplas | Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH) | 0.85 pg |
| Infants ≤2 Years | Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH) | 1.00 pg |
Primary
Monitoring of Clinically Significant Changes in Mean Corpuscular Volume (MCV)
Assesses Pre- and Post-infusion for Infusion Episode 1
Time frame: up to 6 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Octaplas | Monitoring of Clinically Significant Changes in Mean Corpuscular Volume (MCV) | 1.6 fL |
| Infants ≤2 Years | Monitoring of Clinically Significant Changes in Mean Corpuscular Volume (MCV) | 1.85 fL |
Primary
Monitoring of Clinically Significant Changes in Platelets
Assesses Pre- and Post-infusion for Infusion Episode 1
Time frame: up to 6 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Octaplas | Monitoring of Clinically Significant Changes in Platelets | -105.5 10^3/µL |
| Infants ≤2 Years | Monitoring of Clinically Significant Changes in Platelets | -167.00 10^3/µL |
Primary
Monitoring of Clinically Significant Changes in Red Blood Cells
Assesses Pre- and Post-infusion for Infusion Episode 1
Time frame: up to 6 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Octaplas | Monitoring of Clinically Significant Changes in Red Blood Cells | -0.34 10^6/µL |
| Infants ≤2 Years | Monitoring of Clinically Significant Changes in Red Blood Cells | -0.06 10^6/µL |
Primary
Monitoring of Clinically Significant Changes in Red Cell Distribution Width (RDW)
Assesses Pre- and Post-infusion for Infusion Episode 1
Time frame: up to 6 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Octaplas | Monitoring of Clinically Significant Changes in Red Cell Distribution Width (RDW) | 0.10 % variation of RBC size |
| Infants ≤2 Years | Monitoring of Clinically Significant Changes in Red Cell Distribution Width (RDW) | 0.40 % variation of RBC size |
Primary
Monitoring of Clinically Significant Changes in White Blood Cells
Assesses Pre- and Post-infusion for Infusion Episode 1
Time frame: up to 6 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Octaplas | Monitoring of Clinically Significant Changes in White Blood Cells | 5.3 10^3/µL |
| Infants ≤2 Years | Monitoring of Clinically Significant Changes in White Blood Cells | 2.05 10^3/µL |
Primary
Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)
Time frame: up to 6 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octaplas | Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events) | Any SAE | 5 participants |
| Octaplas | Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events) | Any SAE related to Octaplas | 0 participants |
| Octaplas | Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events) | Any ADR | 0 participants |
| Octaplas | Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events) | Any ADR, SAE, HFE TEE, or TE leading to withdrawal | 0 participants |
| Octaplas | Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events) | Any ADR, SAE, HFE, TEE, or TE leading to death | 1 participants |
| Octaplas | Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events) | Any study death related to Octaplas | 0 participants |
Secondary
Count of Investigator's Assessment of Overall Safety Observed for Patients by Category (Assessed to Have Overall Safety of 'Excellent', Assessed to Have Overall Safety of 'Moderate', Assessed to Have Overall Safety of 'Poor')
Time frame: up to 6 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Octaplas | Count of Investigator's Assessment of Overall Safety Observed for Patients by Category (Assessed to Have Overall Safety of 'Excellent', Assessed to Have Overall Safety of 'Moderate', Assessed to Have Overall Safety of 'Poor') | Assessed to have overall safety of 'excellent' | 50 Participants |
| Octaplas | Count of Investigator's Assessment of Overall Safety Observed for Patients by Category (Assessed to Have Overall Safety of 'Excellent', Assessed to Have Overall Safety of 'Moderate', Assessed to Have Overall Safety of 'Poor') | Assessed to have overall safety of 'moderate' | 0 Participants |
| Octaplas | Count of Investigator's Assessment of Overall Safety Observed for Patients by Category (Assessed to Have Overall Safety of 'Excellent', Assessed to Have Overall Safety of 'Moderate', Assessed to Have Overall Safety of 'Poor') | Assessed to have overall safety of 'poor' | 0 Participants |
Secondary
Medically Significant Changes in Blood Pressure
Time frame: up to 6 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Octaplas | Medically Significant Changes in Blood Pressure | Systolic Blood Pressure | 75.66 mm of Hg | Standard Deviation 16.901 |
| Octaplas | Medically Significant Changes in Blood Pressure | Diastolic Blood Pressure | 46.28 mm of Hg | Standard Deviation 10.031 |
| Infants ≤2 Years | Medically Significant Changes in Blood Pressure | Systolic Blood Pressure | 79.96 mm of Hg | Standard Deviation 16.437 |
| Infants ≤2 Years | Medically Significant Changes in Blood Pressure | Diastolic Blood Pressure | 50.00 mm of Hg | Standard Deviation 11.648 |
Secondary
Medically Significant Changes in Body Temperature
Time frame: up to 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Octaplas | Medically Significant Changes in Body Temperature | 35.60 units | Standard Deviation 2.023 |
| Infants ≤2 Years | Medically Significant Changes in Body Temperature | 36.50 units | Standard Deviation 1.597 |
Secondary
Medically Significant Changes in Heart Rate
Time frame: up to 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Octaplas | Medically Significant Changes in Heart Rate | 122.86 beats per minute | Standard Deviation 30.528 |
| Infants ≤2 Years | Medically Significant Changes in Heart Rate | 132.80 beats per minute | Standard Deviation 24.439 |
Secondary
Medically Significant Changes in Oxygen Saturation
Time frame: up to 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Octaplas | Medically Significant Changes in Oxygen Saturation | 96.86 % oxygen in blood | Standard Deviation 5.564 |
| Infants ≤2 Years | Medically Significant Changes in Oxygen Saturation | 98.33 % oxygen in blood | Standard Deviation 3.204 |
Secondary
Medically Significant Changes in Respiratory Rate
Time frame: up to 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Octaplas | Medically Significant Changes in Respiratory Rate | 21.27 breaths/minute | Standard Deviation 7.335 |
| Infants ≤2 Years | Medically Significant Changes in Respiratory Rate | 23.79 breaths/minute | Standard Deviation 6.702 |
Secondary
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)
aPTT measures the length of time (in seconds) that it takes for clotting to occur in a test cube. The higher the number of seconds the longer it takes the blood to clot. The changes between pre - and post infusion were analyzed
Time frame: up to 6 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT) | Remained Normal | 18 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT) | Remained Not Clinically Significant (NCS) | 12 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT) | From (NCS) Not Clinically Significant to Normal | 5 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT) | Shift from Normal to Not Clinically Significant | 9 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT) | NCS to Clinically Significant Shift | 1 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT) | Clinically Significant to NCS shift | 1 participants |
Secondary
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)
This hemostatic parameter is figured out in the lab and helps to diagnose a bleeding disorder or excessive clotting disorder. The change of INR before and after 1st Octaplas infusion was scrutinized by analyzing the shifts between the classifications given below.
Time frame: up to 6 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR) | Shift from Not Clinically Significant to Normal | 1 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR) | Remained Normal | 8 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR) | Remained Not Clinically Significant | 11 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR) | Shift from Normal to Not Clinically Significant | 25 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR) | Shift to or from Clinically Significant | 1 participants |
Secondary
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)
This hemostatic parameter is figured out in the lab and measures the time it takes for your blood to clot (the higher the PT the longer it takes your blood to clot). The change of PT before and after 1st Octaplas infusion was scrutinized by analyzing the shifts between the classifications given below.
Time frame: up to 6 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT) | Shift from Not Clinically Significant to Normal | 1 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT) | Remained Normal | 8 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT) | Remained Not Clinically Significant | 18 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT) | Shift from Normal to Not Clinically Significant | 19 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT) | Shift to or from Clinically Significant | 0 participants |
Secondary
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).
TEG and ROTEM are methods of testing the efficiency of blood coagulation. The results were compared by looking at potential trends from TEG and ROTEM between pre-infusion vs post-infusion time points.
Time frame: up to 6 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM). | Remained Normal | 40 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM). | Shift from Normal to Not Clinically Significant | 0 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM). | Remained Not Clinically Significant | 0 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM). | Shift to or from Clinically Significant | 0 participants |
| Octaplas | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM). | Shift from Not Clinically Significant to Normal | 1 participants |
| Infants ≤2 Years | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM). | Shift to or from Clinically Significant | 0 participants |
| Infants ≤2 Years | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM). | Shift from Not Clinically Significant to Normal | 0 participants |
| Infants ≤2 Years | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM). | Remained Normal | 0 participants |
| Infants ≤2 Years | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM). | Remained Not Clinically Significant | 0 participants |
| Infants ≤2 Years | Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM). | Shift from Normal to Not Clinically Significant | 0 participants |
Secondary
Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient.
Normal infusion: Replacement of multiple clotting factors Bypass priming: Limit hemodilution and reduce transfusion requirements Bypass warming up: Rewarm patients suffering from hypothermia during the surgery process
Time frame: up to 6 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Octaplas | Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient. | Normal Infusion | 15 mL/kg | Standard Deviation 14.17 |
| Octaplas | Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient. | Bypass Priming | 20.2 mL/kg | Standard Deviation 7.82 |
| Octaplas | Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient. | Bypass Warming Up | 15.9 mL/kg | Standard Deviation 5.88 |