Octaplas Pediatric Plasma Replacement Trial

• Sponsor: Octapharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02050841
• Collaborator: (none)
• Enrollment: 50
• Locations: 4
• Arm: 1
• Duration (Months): 36.1
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Surgery; Liver Dysfunction; Coagulopathy; Cardiac Surgery	Biological: octaplas	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Multicenter, Post-Marketing Requirement (PMR) Study to Investigate the Safety, Tolerability and Efficacy of Octaplas in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors.
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Dec 4, 2017
• Actual Study Completion Date: Dec 4, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Octaplas Qualified patients will receive Octaplas as per protocol.	Biological: octaplas; Octaplas S/D Plasma

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events) [up to 6 days]

2. Monitoring of Clinically Significant Changes in White Blood Cells [up to 6 days]

   Assesses Pre- and Post-infusion for Infusion Episode 1

3. Monitoring of Clinically Significant Changes in Red Blood Cells [up to 6 days]

   Assesses Pre- and Post-infusion for Infusion Episode 1

4. Monitoring of Clinically Significant Changes in Hemoglobin [up to 6 days]

   Assesses Pre- and Post-infusion for Infusion Episode 1

5. Monitoring of Clinically Significant Changes in Hematocrit [up to 6 days]

   Assesses Pre- and Post-infusion for Infusion Episode 1

6. Monitoring of Clinically Significant Changes in Mean Corpuscular Volume (MCV) [up to 6 days]

   Assesses Pre- and Post-infusion for Infusion Episode 1

7. Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH) [up to 6 days]

   Assesses Pre- and Post-infusion for Infusion Episode 1

8. Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC) [up to 6 days]

   Assesses Pre- and Post-infusion for Infusion Episode 1

9. Monitoring of Clinically Significant Changes in Red Cell Distribution Width (RDW) [up to 6 days]

   Assesses Pre- and Post-infusion for Infusion Episode 1

10. Monitoring of Clinically Significant Changes in Platelets [up to 6 days]

    Assesses Pre- and Post-infusion for Infusion Episode 1

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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

5. 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

6. Medically Significant Changes in Blood Pressure [up to 6 days]

7. Medically Significant Changes in Heart Rate [up to 6 days]

8. Medically Significant Changes in Respiratory Rate [up to 6 days]

9. Medically Significant Changes in Oxygen Saturation [up to 6 days]

10. Medically Significant Changes in Body Temperature [up to 6 days]

11. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 16 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Octapharma Research Site	Birmingham	Alabama	United States	35233
2	Octapharma Research Site	Atlanta	Georgia	United States	30322
3	Octapharma Research Site	Minneapolis	Minnesota	United States	55455
4	Octapharma Research Site	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Octapharma

Investigators

• Study Director: Wolfgang Frenzel, International Medical Director

Study Documents (Full-Text)

• Study Protocol - Nov 19, 2016
• Statistical Analysis Plan - Dec 1, 2017

More Information

Publications

None provided.

• Responsible Party: Octapharma
• ClinicalTrials.gov Identifier: NCT02050841
• Other Study ID Numbers: LAS-212
• First Posted: Jan 31, 2014
• Last Update Posted: Jun 23, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Keywords provided by Octapharma: Pediatric; patients; replacement; coagulation factors; plasma; s/d plasma; Octaplas; plasma replacement
• Additional relevant MeSH terms: Liver Diseases

Study Results

Participant Flow

Arm/Group Title	Octaplas
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Period Title: Overall Study
STARTED	50
COMPLETED	49
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Octaplas
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Overall Participants	50
Age (Count of Participants)
<=18 years	50 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	2.0 (3.98)
Sex: Female, Male (Count of Participants)
Female	24 48%
Male	26 52%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2%
Not Hispanic or Latino	49 98%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 2%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	14 28%
White	34 68%
More than one race	0 0%
Unknown or Not Reported	1 2%
ABO Blood Group (Count of Participants)
A	16 32%
B	9 18%
AB	4 8%
O	21 42%
Height (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	78.1 (30.49)
Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	13.66 (21.589)
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	16.88 (5.421)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)
Time Frame	up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Octaplas
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Measure Participants	50
Any SAE	5 10%
Any SAE related to Octaplas	0 0%
Any ADR	0 0%
Any ADR, SAE, HFE TEE, or TE leading to withdrawal	0 0%
Any ADR, SAE, HFE, TEE, or TE leading to death	1 2%
Any study death related to Octaplas	0 0%

2. Primary Outcome

Title	Monitoring of Clinically Significant Changes in White Blood Cells
Description	Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame	up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children >2 Years	Infants ≤2 Years
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Measure Participants	13	37
Median (Full Range) [10^3/µL]	5.3	2.05

3. Primary Outcome

Title	Monitoring of Clinically Significant Changes in Red Blood Cells
Description	Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame	up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children >2 Years	Infants ≤2 Years
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Measure Participants	13	37
Median (Full Range) [10^6/µL]	-0.34	-0.06

4. Primary Outcome

Title	Monitoring of Clinically Significant Changes in Hemoglobin
Description	Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame	up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children >2 Years	Infants ≤2 Years
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Measure Participants	13	37
Median (Full Range) [g/dL]	-0.70	0.80

5. Primary Outcome

Title	Monitoring of Clinically Significant Changes in Hematocrit
Description	Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame	up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children >2 Years	Infants ≤2 Years
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Measure Participants	13	37
Median (Full Range) [volume percentage of RBC in blood]	-2.35	1.35

6. Primary Outcome

Title	Monitoring of Clinically Significant Changes in Mean Corpuscular Volume (MCV)
Description	Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame	up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children >2 Years	Infants ≤2 Years
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Measure Participants	13	37
Median (Full Range) [fL]	1.6	1.85

7. Primary Outcome

Title	Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH)
Description	Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame	up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children >2 Years	Infants ≤2 Years
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Measure Participants	13	37
Median (Full Range) [pg]	0.85	1.00

8. Primary Outcome

Title	Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC)
Description	Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame	up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children >2 Years	Infants ≤2 Years
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Measure Participants	13	37
Median (Full Range) [g/dL]	-0.15	0.20

9. Primary Outcome

Title	Monitoring of Clinically Significant Changes in Red Cell Distribution Width (RDW)
Description	Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame	up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children >2 Years	Infants ≤2 Years
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Measure Participants	13	37
Median (Full Range) [% variation of RBC size]	0.10	0.40

10. Primary Outcome

Title	Monitoring of Clinically Significant Changes in Platelets
Description	Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame	up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children >2 Years	Infants ≤2 Years
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Measure Participants	13	37
Median (Full Range) [10^3/µL]	-105.5	-167.00

11. Secondary Outcome

Title	Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Octaplas
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Measure Participants	50
Shift from Not Clinically Significant to Normal	1 2%
Remained Normal	8 16%
Remained Not Clinically Significant	11 22%
Shift from Normal to Not Clinically Significant	25 50%
Shift to or from Clinically Significant	1 2%

12. Secondary Outcome

Title	Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Octaplas
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Measure Participants	50
Shift from Not Clinically Significant to Normal	1 2%
Remained Normal	8 16%
Remained Not Clinically Significant	18 36%
Shift from Normal to Not Clinically Significant	19 38%
Shift to or from Clinically Significant	0 0%

13. Secondary Outcome

Title	Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EPL30-TEG	ML30-ROTEM
Arm/Group Description	Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by EPL30-TEG (estimated percent lysis)	Number of Participants WithClinically Significant Changes in Hemostatic Parameters as Measured byThromboelastometry (ROTEM).
Measure Participants	50	50
Shift from Not Clinically Significant to Normal	1 2%	0 NaN
Remained Normal	40 80%	0 NaN
Remained Not Clinically Significant	0 0%	0 NaN
Shift from Normal to Not Clinically Significant	0 0%	0 NaN
Shift to or from Clinically Significant	0 0%	0 NaN

14. Secondary Outcome

Title	Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Octaplas
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Measure Participants	50
From (NCS) Not Clinically Significant to Normal	5 10%
Remained Normal	18 36%
Remained Not Clinically Significant (NCS)	12 24%
Shift from Normal to Not Clinically Significant	9 18%
NCS to Clinically Significant Shift	1 2%
Clinically Significant to NCS shift	1 2%

15. Secondary Outcome

Title	Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Octaplas
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Measure Participants	50
Normal Infusion	15 (14.17)
Bypass Priming	20.2 (7.82)
Bypass Warming Up	15.9 (5.88)

16. Secondary Outcome

Title	Medically Significant Changes in Blood Pressure
Time Frame	up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Octaplas - Pre-Infusion	Octaplas - Post-Infusion
Arm/Group Description	Pre-Infusion Vital Signs	Post-Infusion Vital Signs
Measure Participants	50	50
Systolic Blood Pressure	75.66 (16.901)	79.96 (16.437)
Diastolic Blood Pressure	46.28 (10.031)	50.00 (11.648)

17. Secondary Outcome

Title	Medically Significant Changes in Heart Rate
Time Frame	up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Octaplas - Pre-Infusion	Octaplas - Post-Infusion
Arm/Group Description	Pre-Infusion Vital Signs	Post-Infusion Vital Signs
Measure Participants	50	50
Mean (Standard Deviation) [beats per minute]	122.86 (30.528)	132.80 (24.439)

18. Secondary Outcome

Title	Medically Significant Changes in Respiratory Rate
Time Frame	up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Octaplas - Pre-Infusion	Octaplas - Post-Infusion
Arm/Group Description	Pre-Infusion Vital Signs	Post-Infusion Vital Signs
Measure Participants	50	50
Mean (Standard Deviation) [breaths/minute]	21.27 (7.335)	23.79 (6.702)

19. Secondary Outcome

Title	Medically Significant Changes in Oxygen Saturation
Time Frame	up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Octaplas - Pre-Infusion	Octaplas - Post-Infusion
Arm/Group Description	Pre-Infusion Vital Signs	Post-Infusion Vital Signs
Measure Participants	50	50
Mean (Standard Deviation) [% oxygen in blood]	96.86 (5.564)	98.33 (3.204)

20. Secondary Outcome

Title	Medically Significant Changes in Body Temperature
Time Frame	up to 6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Octaplas - Pre-Infusion	Octaplas - Post-Infusion
Arm/Group Description	Pre-Infusion Vital Signs	Post-Infusion Vital Signs
Measure Participants	50	50
Mean (Standard Deviation) [units]	35.60 (2.023)	36.50 (1.597)

21. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Octaplas
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
Measure Participants	50
Assessed to have overall safety of 'excellent'	50 100%
Assessed to have overall safety of 'moderate'	0 0%
Assessed to have overall safety of 'poor'	0 0%

Adverse Events

Time Frame	Adverse event data were collected for each participant over the course of 6 days
Adverse Event Reporting Description	Any of the following drug safety information was collected after the start of the first infusion episode: Serious adverse events Adverse drug reactions temporally associated with administration of the investigational product Adverse events that fall into the category of TEs, TEEs and hyperfibrinolytic events Post-treatment related safety reports, pregnancies, drug overdose, interaction, abuse, misuse, medication error, lack of efficacy
Arm/Group Title	Octaplas
Arm/Group Description	Qualified patients will receive Octaplas as per protocol. octaplas: Octaplas S/D Plasma
All Cause Mortality
	Octaplas
	Affected / at Risk (%)	# Events
Total	1/50 (2%)
Serious Adverse Events
	Octaplas
	Affected / at Risk (%)	# Events
Total	5/50 (10%)
Cardiac disorders
Supraventricular tachycardia	1/50 (2%)	1
Intracardiac thrombus	1/50 (2%)	1
Hypotension	1/50 (2%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/50 (2%)	1
Surgical and medical procedures
Iatrogenic injury	1/50 (2%)	1
Vascular disorders
Portal vein thrombosis	1/50 (2%)	1
Haemorrhage	1/50 (2%)	1
Shock haemorrhagic	1/50 (2%)	1
Haemorrhage coronary artery	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	Octaplas
	Affected / at Risk (%)	# Events
Total	0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.