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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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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 : December 2014
Actual Primary Completion Date : December 4, 2017
Actual Study Completion Date : December 4, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Octaplas

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




Primary Outcome Measures :
  1. Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events) [ Time Frame: up to 6 days ]
  2. Monitoring of Clinically Significant Changes in White Blood Cells [ Time Frame: up to 6 days ]
    Assesses Pre- and Post-infusion for Infusion Episode 1

  3. Monitoring of Clinically Significant Changes in Red Blood Cells [ Time Frame: up to 6 days ]
    Assesses Pre- and Post-infusion for Infusion Episode 1

  4. Monitoring of Clinically Significant Changes in Hemoglobin [ Time Frame: up to 6 days ]
    Assesses Pre- and Post-infusion for Infusion Episode 1

  5. Monitoring of Clinically Significant Changes in Hematocrit [ Time Frame: up to 6 days ]
    Assesses Pre- and Post-infusion for Infusion Episode 1

  6. 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

  7. 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

  8. 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

  9. 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

  10. Monitoring of Clinically Significant Changes in Platelets [ Time Frame: 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) [ 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. Medically Significant Changes in Blood Pressure [ Time Frame: up to 6 days ]
  7. Medically Significant Changes in Heart Rate [ Time Frame: up to 6 days ]
  8. Medically Significant Changes in Respiratory Rate [ Time Frame: up to 6 days ]
  9. Medically Significant Changes in Oxygen Saturation [ Time Frame: up to 6 days ]
  10. Medically Significant Changes in Body Temperature [ Time Frame: 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') [ Time Frame: up to 6 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050841


Locations
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United States, Alabama
Octapharma Research Site
Birmingham, Alabama, United States, 35233
United States, Georgia
Octapharma Research Site
Atlanta, Georgia, United States, 30322
United States, Minnesota
Octapharma Research Site
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Octapharma Research Site
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Octapharma
Investigators
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Study Director: Wolfgang Frenzel International Medical Director
  Study Documents (Full-Text)

Documents provided by Octapharma:
Study Protocol  [PDF] November 19, 2016
Statistical Analysis Plan  [PDF] December 1, 2017


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Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT02050841     History of Changes
Other Study ID Numbers: LAS-212
First Posted: January 31, 2014    Key Record Dates
Results First Posted: March 25, 2019
Last Update Posted: March 25, 2019
Last Verified: March 2019

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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:
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Blood Coagulation Disorders
Hemostatic Disorders
Liver Diseases
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Digestive System Diseases