Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pathogen Reduction Evaluation & Predictive Analytical Rating Score (PREPAReS)

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: NCT02783313
Recruitment Status : Completed
First Posted : May 26, 2016
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Terumo BCT
Information provided by (Responsible Party):
Sanquin Research & Blood Bank Divisions

Brief Summary:
The objective of this study is to determine if pooled buffy coat-derived pathogen reduced plasma-stored platelet concentrates are non-inferior compared to plasma-stored platelet concentrates in terms of WHO bleeding complications in hemato-oncological patients with thrombocytopenia.

Condition or disease Intervention/treatment Phase
Thrombocytopenia Device: Pathogen reduced plasma-stored platelet concentrates Other: Plasma-stored platelet concentrates Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 567 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Effectiveness of Standard Versus Pathogen-reduced Buffy Coat-derived Platelet Concentrates in Plasma in Hemato-oncological Patients.
Study Start Date : November 17, 2010
Actual Primary Completion Date : April 30, 2016
Actual Study Completion Date : June 30, 2016

Arm Intervention/treatment
Experimental: PR-plasma-PCs
Pooled buffy coat-derived pathogen reduced plasma-stored platelet concentrates (PR-plasma-PCs)
Device: Pathogen reduced plasma-stored platelet concentrates
Platelet concentrates treated with the Mirasol PRT system (pathogen reduction technology) and stored in plasma.

Active Comparator: Plasma-PCs
Pooled buffy coat-derived plasma-stored platelet concentrates (plasma-PCs)
Other: Plasma-stored platelet concentrates
Platelet concentrates stored in plasma




Primary Outcome Measures :
  1. Percentage of patients with WHO grade ≥ 2 bleeding complications [ Time Frame: Transfusion episode (from the day of the first on-study transfusion until study completion), an average of 20 days ]
    Any WHO grade ≥ 2 bleeding event, as determined by daily assessment of bleeding symptoms, and documentation of any red blood cell transfusions to treat bleeding


Secondary Outcome Measures :
  1. 1 and 24 hour count increment [ Time Frame: 1 and 24 hours post-transfusion ]
  2. 1 and 24 hour corrected count increment (CCI) [ Time Frame: 1 and 24 hours post-transfusion ]
  3. (1+24 hour CCI)/2 [ Time Frame: 1 and 24 hours post-transfusion ]
  4. Adverse transfusion reactions [ Time Frame: On-study episode (from the day of randomization until study completion), an average of 25 days ]
    All transfusion-associated side effects observed within 6 hours after platelet transfusion

  5. Total transfusion requirement of red cells and platelets [ Time Frame: Transfusion episode (from the day of the first on-study transfusion until study completion), an average of 20 days ]
    Number of occurrences of a platelet transfusion or a red cell transfusion among subjects who have had at least one platelet transfusion

  6. Platelet transfusion interval [ Time Frame: Transfusion episode (from the day of the first on-study transfusion until study completion), an average of 20 days ]
    Time in hours between the last and first occurrence of a platelet transfusion, divided by the number of platelet transfusion occurrences minus 1, among subjects who have had at least two platelet transfusions

  7. Rate of HLA allo-immunization [ Time Frame: From the day of randomization until 56 days after randomization ]
  8. In vitro quality markers related with the 1-hour or 24-hour CCI [ Time Frame: 1 and 24 hours post-transfusion ]
  9. Clinical factors interacting on primary endpoint, including in vivo variables of immunological responses; and of hemostasis in the recipients after transfusion as compared prior to transfusion. [ Time Frame: Transfusion episode (from the day of the first on-study transfusion until study completion), an average of 20 days ]
    Severity of the WHO bleeding grade as determined by daily assessment of bleeding symptoms, related to the level of circulating HLA allo antibodies as determined in a blood sample collected every week during the on-study episode; severity of the WHO bleeding grade as determined by daily assessment of bleeding symptoms at the day of occurrence of a platelet transfusion as compared to the day after the occurrence of a platelet transfusion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. Expected ≥ 2 platelet transfusion requirements;
  3. Signed informed consent;
  4. Having hemato oncological disease including those who undergo myelo ablative allogeneic stem cell transplant therapy.

Exclusion Criteria:

  1. Micro-angiopathic thrombocytopenia (TTP, HUS) and ITP;
  2. Bleeding > grade 2 at randomization ( after treatment, the patient can be randomized in the study after 2 or more weeks after the last transfusion that was used to stop the bleeding);
  3. Known immunological refractoriness to platelet transfusions;
  4. HLA- and/or HPA-allo immunization and/or clinical relevant auto-antibodies;
  5. Indications to use hyper-concentrated (plasma-reduced) platelet concentrates, i.e. patients with known severe allergic reactions and documented transfusion-associated circulatory overload (TACO);
  6. Pregnancy (or lactating);
  7. Prior treatment with pathogen-reduced blood products;
  8. Known allergy to riboflavin or its photoactive products.

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): NCT02783313


Locations
Layout table for location information
Canada
McMaster University
Hamilton, Canada
Kingston General Hospital
Kingston, Canada
London Health Sciences Centre
London, Canada
Ottawa Hospital
Ottawa, Canada
Sunnybrook Health Sciences Centre
Toronto, Canada
Netherlands
Leiden University Medical Center
Leiden, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Haga Ziekenhuis
The Hague, Netherlands
Norway
Haukeland University Hospital
Bergen, Norway
Sponsors and Collaborators
Sanquin Research & Blood Bank Divisions
Terumo BCT
Investigators
Layout table for investigator information
Principal Investigator: Jean-Louis Kerkhoffs, MD, PhD Sanquin Blood Bank

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier: NCT02783313    
Other Study ID Numbers: ABR30643
NTR2106 ( Registry Identifier: Dutch Trial Register )
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sanquin Research & Blood Bank Divisions:
pathogen inactivation
platelets
Additional relevant MeSH terms:
Layout table for MeSH terms
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases