- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02050841
Octaplas Pediatric Plasma Replacement Trial
June 9, 2020 updated by: Octapharma
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.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- Octapharma Research Site
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Georgia
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Atlanta, Georgia, United States, 30322
- Octapharma Research Site
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Octapharma Research Site
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Missouri
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Saint Louis, Missouri, United States, 63110
- Octapharma Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient requiring liver or cardiac surgery and/or patient with liver dysfunction associated with coagulopathy in whom replacement of multiple coagulation factors is required.
- 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.
- Male or female patient ≤ 16 years of age.
Exclusion Criteria:
- Patient with known homozygous congenital deficiency of protein S.
- Patient has a history of hypersensitivity reaction to blood or plasma-derived products or to any excipient of the investigational product.
- Patient has an already known IgA (Immunoglobulin A) deficiency with documented antibodies against IgA.
- Patient has a congenital factor deficiency or platelet disorder requiring plasma treatment.
- 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.
- 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.
- Patient is on ECMO (Extracorporeal Membrane Oxygenation) when plasma is ordered by the treating physician for the first infusion episode.
- Patient is pregnant.
- 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
- Patient is receiving plasma exchange, therapeutic plasma exchange (TPE) or plasmapheresis.
- Patient is a premature neonate defined as less than 37 weeks gestation.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Octaplas
Qualified patients will receive Octaplas as per protocol.
|
Octaplas S/D Plasma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)
Time Frame: up to 6 days
|
up to 6 days
|
|
Monitoring of Clinically Significant Changes in White Blood Cells
Time Frame: up to 6 days
|
Assesses Pre- and Post-infusion for Infusion Episode 1
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up to 6 days
|
Monitoring of Clinically Significant Changes in Red Blood Cells
Time Frame: up to 6 days
|
Assesses Pre- and Post-infusion for Infusion Episode 1
|
up to 6 days
|
Monitoring of Clinically Significant Changes in Hemoglobin
Time Frame: up to 6 days
|
Assesses Pre- and Post-infusion for Infusion Episode 1
|
up to 6 days
|
Monitoring of Clinically Significant Changes in Hematocrit
Time Frame: up to 6 days
|
Assesses Pre- and Post-infusion for Infusion Episode 1
|
up to 6 days
|
Monitoring of Clinically Significant Changes in Mean Corpuscular Volume (MCV)
Time Frame: up to 6 days
|
Assesses Pre- and Post-infusion for Infusion Episode 1
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up to 6 days
|
Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH)
Time Frame: up to 6 days
|
Assesses Pre- and Post-infusion for Infusion Episode 1
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up to 6 days
|
Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC)
Time Frame: up to 6 days
|
Assesses Pre- and Post-infusion for Infusion Episode 1
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up to 6 days
|
Monitoring of Clinically Significant Changes in Red Cell Distribution Width (RDW)
Time Frame: up to 6 days
|
Assesses Pre- and Post-infusion for Infusion Episode 1
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up to 6 days
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Monitoring of Clinically Significant Changes in Platelets
Time Frame: up to 6 days
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Assesses Pre- and Post-infusion for Infusion Episode 1
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up to 6 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)
Time Frame: 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.
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up to 6 days
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)
Time Frame: 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.
|
up to 6 days
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).
Time Frame: 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.
|
up to 6 days
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)
Time Frame: 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
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up to 6 days
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Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient.
Time Frame: up to 6 days
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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
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up to 6 days
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Medically Significant Changes in Blood Pressure
Time Frame: up to 6 days
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up to 6 days
|
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Medically Significant Changes in Heart Rate
Time Frame: up to 6 days
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up to 6 days
|
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Medically Significant Changes in Respiratory Rate
Time Frame: up to 6 days
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up to 6 days
|
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Medically Significant Changes in Oxygen Saturation
Time Frame: up to 6 days
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up to 6 days
|
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Medically Significant Changes in Body Temperature
Time Frame: up to 6 days
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up to 6 days
|
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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
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up to 6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
December 4, 2017
Study Completion (Actual)
December 4, 2017
Study Registration Dates
First Submitted
January 21, 2014
First Submitted That Met QC Criteria
January 30, 2014
First Posted (Estimate)
January 31, 2014
Study Record Updates
Last Update Posted (Actual)
June 23, 2020
Last Update Submitted That Met QC Criteria
June 9, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LAS-212
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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