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Octaplas Pediatric Plasma Replacement Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02050841
Recruitment Status : Completed
First Posted : January 31, 2014
Results First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Octapharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Liver Surgery
Liver Dysfunction
Coagulopathy
Cardiac Surgery
Intervention Biological: octaplas
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Octaplas
Hide Arm/Group Description

Qualified patients will receive Octaplas as per protocol.

octaplas: Octaplas S/D Plasma

Period Title: Overall Study
Started 50
Completed 50
Not Completed 0
Arm/Group Title Octaplas
Hide Arm/Group Description

Qualified patients will receive Octaplas as per protocol.

octaplas: Octaplas S/D Plasma

Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
<=18 years
50
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
2.0  (3.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
24
  48.0%
Male
26
  52.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Hispanic or Latino
1
   2.0%
Not Hispanic or Latino
49
  98.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
14
  28.0%
White
34
  68.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.0%
ABO Blood Group  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
A
16
  32.0%
B
9
  18.0%
AB
4
   8.0%
O
21
  42.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 50 participants
78.1  (30.49)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 50 participants
13.66  (21.589)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 50 participants
16.88  (5.421)
1.Primary Outcome
Title Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)
Hide Description [Not Specified]
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Octaplas
Hide Arm/Group Description:

Qualified patients will receive Octaplas as per protocol.

octaplas: Octaplas S/D Plasma

Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
Any SAE 5
Any SAE related to Octaplas 0
Any ADR 0
Any ADR, SAE, HFE TEE, or TE leading to withdrawal 0
Any ADR, SAE, HFE, TEE, or TE leading to death 1
Any study death related to Octaplas 0
2.Primary Outcome
Title Monitoring of Clinically Significant Changes in White Blood Cells
Hide Description Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children >2 Years Infants ≤2 Years
Hide 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

Overall Number of Participants Analyzed 13 37
Median (Full Range)
Unit of Measure: 10^3/µL
5.3
(-4.7 to 28.3)
2.05
(-12.3 to 9.3)
3.Primary Outcome
Title Monitoring of Clinically Significant Changes in Red Blood Cells
Hide Description Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children >2 Years Infants ≤2 Years
Hide 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

Overall Number of Participants Analyzed 13 37
Median (Full Range)
Unit of Measure: 10^6/µL
-0.34
(-1.4 to 0.6)
-0.06
(-1.8 to 1.8)
4.Primary Outcome
Title Monitoring of Clinically Significant Changes in Hemoglobin
Hide Description Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children >2 Years Infants ≤2 Years
Hide 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

Overall Number of Participants Analyzed 13 37
Median (Full Range)
Unit of Measure: g/dL
-0.70
(-3.9 to 2.7)
0.80
(-4.6 to 5.2)
5.Primary Outcome
Title Monitoring of Clinically Significant Changes in Hematocrit
Hide Description Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children >2 Years Infants ≤2 Years
Hide 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

Overall Number of Participants Analyzed 13 37
Median (Full Range)
Unit of Measure: volume percentage of RBC in blood
-2.35
(-10.8 to 6.5)
1.35
(-14.6 to 16.2)
6.Primary Outcome
Title Monitoring of Clinically Significant Changes in Mean Corpuscular Volume (MCV)
Hide Description Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children >2 Years Infants ≤2 Years
Hide 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

Overall Number of Participants Analyzed 13 37
Median (Full Range)
Unit of Measure: fL
1.6
(-5.4 to 6.3)
1.85
(-22.8 to 9.1)
7.Primary Outcome
Title Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH)
Hide Description Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children >2 Years Infants ≤2 Years
Hide 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

Overall Number of Participants Analyzed 13 37
Median (Full Range)
Unit of Measure: pg
0.85
(-1.8 to 2.9)
1.00
(-8.3 to 5.6)
8.Primary Outcome
Title Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC)
Hide Description Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children >2 Years Infants ≤2 Years
Hide 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

Overall Number of Participants Analyzed 13 37
Median (Full Range)
Unit of Measure: g/dL
-0.15
(-0.9 to 4.2)
0.20
(-1.2 to 2.8)
9.Primary Outcome
Title Monitoring of Clinically Significant Changes in Red Cell Distribution Width (RDW)
Hide Description Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children >2 Years Infants ≤2 Years
Hide 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

Overall Number of Participants Analyzed 13 37
Median (Full Range)
Unit of Measure: % variation of RBC size
0.10
(-3.9 to 3.0)
0.40
(-2.1 to 4.2)
10.Primary Outcome
Title Monitoring of Clinically Significant Changes in Platelets
Hide Description Assesses Pre- and Post-infusion for Infusion Episode 1
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children >2 Years Infants ≤2 Years
Hide 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

Overall Number of Participants Analyzed 13 37
Median (Full Range)
Unit of Measure: 10^3/µL
-105.5
(-210.0 to 15.0)
-167.00
(-410.0 to 215.0)
11.Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Octaplas
Hide Arm/Group Description:

Qualified patients will receive Octaplas as per protocol.

octaplas: Octaplas S/D Plasma

Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
Shift from Not Clinically Significant to Normal 1
Remained Normal 8
Remained Not Clinically Significant 11
Shift from Normal to Not Clinically Significant 25
Shift to or from Clinically Significant 1
12.Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Octaplas
Hide Arm/Group Description:

Qualified patients will receive Octaplas as per protocol.

octaplas: Octaplas S/D Plasma

Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
Shift from Not Clinically Significant to Normal 1
Remained Normal 8
Remained Not Clinically Significant 18
Shift from Normal to Not Clinically Significant 19
Shift to or from Clinically Significant 1
13.Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EPL30-TEG ML30-ROTEM
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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).
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: participants
Shift from Not Clinically Significant to Normal 1 0
Remained Normal 40 0
Remained Not Clinically Significant 0 0
Shift from Normal to Not Clinically Significant 0 0
Shift to or from Clinically Significant 0 0
14.Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Octaplas
Hide Arm/Group Description:

Qualified patients will receive Octaplas as per protocol.

octaplas: Octaplas S/D Plasma

Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
From (NCS) Not Clinically Significant to Normal 5
Remained Normal 18
Remained Not Clinically Significant (NCS) 12
Shift from Normal to Not Clinically Significant 9
NCS to Clinically Significant Shift 1
Clinically Significant to NCS shift 1
15.Secondary Outcome
Title Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Octaplas
Hide Arm/Group Description:

Qualified patients will receive Octaplas as per protocol.

octaplas: Octaplas S/D Plasma

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: mL/kg
Normal Infusion 9.4  (9.97)
Bypass Priming 19.5  (8.32)
Bypass Warming Up 14.3  (6.78)
16.Secondary Outcome
Title Medically Significant Changes in Blood Pressure
Hide Description [Not Specified]
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Octaplas - Pre-Infusion Octaplas - Post-Infusion
Hide Arm/Group Description:
Pre-Infusion Vital Signs
Post-Infusion Vital Signs
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: mm of Hg
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
Hide Description [Not Specified]
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Octaplas - Pre-Infusion Octaplas - Post-Infusion
Hide Arm/Group Description:
Pre-Infusion Vital Signs
Post-Infusion Vital Signs
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: beats per minute
122.86  (30.528) 132.80  (24.439)
18.Secondary Outcome
Title Medically Significant Changes in Respiratory Rate
Hide Description [Not Specified]
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Octaplas - Pre-Infusion Octaplas - Post-Infusion
Hide Arm/Group Description:
Pre-Infusion Vital Signs
Post-Infusion Vital Signs
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: breaths/minute
21.27  (7.335) 23.79  (6.702)
19.Secondary Outcome
Title Medically Significant Changes in Oxygen Saturation
Hide Description [Not Specified]
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Octaplas - Pre-Infusion Octaplas - Post-Infusion
Hide Arm/Group Description:
Pre-Infusion Vital Signs
Post-Infusion Vital Signs
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: % oxygen in blood
96.86  (5.564) 98.33  (3.204)
20.Secondary Outcome
Title Medically Significant Changes in Body Temperature
Hide Description [Not Specified]
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Octaplas - Pre-Infusion Octaplas - Post-Infusion
Hide Arm/Group Description:
Pre-Infusion Vital Signs
Post-Infusion Vital Signs
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: 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')
Hide Description [Not Specified]
Time Frame up to 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Octaplas
Hide Arm/Group Description:

Qualified patients will receive Octaplas as per protocol.

octaplas: Octaplas S/D Plasma

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
Assessed to have overall safety of 'excellent'
50
 100.0%
Assessed to have overall safety of 'moderate'
0
   0.0%
Assessed to have overall safety of 'poor'
0
   0.0%
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
Hide Arm/Group Description

Qualified patients will receive Octaplas as per protocol.

octaplas: Octaplas S/D Plasma

All-Cause Mortality
Octaplas
Affected / at Risk (%)
Total   1/50 (2.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Octaplas
Affected / at Risk (%) # Events
Total   5/50 (10.00%)    
Cardiac disorders   
Supraventricular tachycardia   1/50 (2.00%)  1
Intracardiac thrombus   1/50 (2.00%)  1
Hypotension   1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory failure   1/50 (2.00%)  1
Surgical and medical procedures   
Iatrogenic injury   1/50 (2.00%)  1
Vascular disorders   
Portal vein thrombosis   1/50 (2.00%)  1
Haemorrhage   1/50 (2.00%)  1
Shock haemorrhagic   1/50 (2.00%)  1
Haemorrhage coronary artery   1/50 (2.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Octaplas
Affected / at Risk (%) # Events
Total   0/50 (0.00%)    
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.
Results Point of Contact
Name/Title: Michael Eppolito
Organization: Octapharma
Phone: 2016041155
Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT02050841     History of Changes
Other Study ID Numbers: LAS-212
First Submitted: January 21, 2014
First Posted: January 31, 2014
Results First Submitted: January 7, 2019
Results First Posted: March 25, 2019
Last Update Posted: March 25, 2019