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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Octapharma Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Octapharma Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Octapharma Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Octapharma Research Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Octaplas
Qualified patients will receive Octaplas as per protocol.
Biological: octaplas
Octaplas S/D Plasma

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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
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
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
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
up to 6 days
Monitoring of Clinically Significant Changes in Platelets
Time Frame: up to 6 days
Assesses Pre- and Post-infusion for Infusion Episode 1
up to 6 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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
up to 6 days
Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient.
Time Frame: 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
up to 6 days
Medically Significant Changes in Blood Pressure
Time Frame: up to 6 days
up to 6 days
Medically Significant Changes in Heart Rate
Time Frame: up to 6 days
up to 6 days
Medically Significant Changes in Respiratory Rate
Time Frame: up to 6 days
up to 6 days
Medically Significant Changes in Oxygen Saturation
Time Frame: up to 6 days
up to 6 days
Medically Significant Changes in Body Temperature
Time Frame: up to 6 days
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')
Time Frame: up to 6 days
up to 6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Octapharma

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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