Pathogen Reduction Evaluation & Predictive Analytical Rating Score
PREPAReS
Clinical Effectiveness of Standard Versus Pathogen-reduced Buffy Coat-derived Platelet Concentrates in Plasma in Hemato-oncological Patients.
2 other identifiers
interventional
567
3 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2010
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 17, 2010
CompletedFirst Submitted
Initial submission to the registry
April 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2016
CompletedFirst Posted
Study publicly available on registry
May 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2016
CompletedAugust 23, 2018
August 1, 2018
5.5 years
April 11, 2016
August 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients with WHO grade ≥ 2 bleeding complications
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
Transfusion episode (from the day of the first on-study transfusion until study completion), an average of 20 days
Secondary Outcomes (9)
1 and 24 hour count increment
1 and 24 hours post-transfusion
1 and 24 hour corrected count increment (CCI)
1 and 24 hours post-transfusion
(1+24 hour CCI)/2
1 and 24 hours post-transfusion
Adverse transfusion reactions
On-study episode (from the day of randomization until study completion), an average of 25 days
Total transfusion requirement of red cells and platelets
Transfusion episode (from the day of the first on-study transfusion until study completion), an average of 20 days
- +4 more secondary outcomes
Study Arms (2)
PR-plasma-PCs
EXPERIMENTALPooled buffy coat-derived pathogen reduced plasma-stored platelet concentrates (PR-plasma-PCs)
Plasma-PCs
ACTIVE COMPARATORPooled buffy coat-derived plasma-stored platelet concentrates (plasma-PCs)
Interventions
Platelet concentrates treated with the Mirasol PRT system (pathogen reduction technology) and stored in plasma.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years;
- Expected ≥ 2 platelet transfusion requirements;
- Signed informed consent;
- Having hemato oncological disease including those who undergo myelo ablative allogeneic stem cell transplant therapy.
You may not qualify if:
- Micro-angiopathic thrombocytopenia (TTP, HUS) and ITP;
- 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);
- Known immunological refractoriness to platelet transfusions;
- HLA- and/or HPA-allo immunization and/or clinical relevant auto-antibodies;
- Indications to use hyper-concentrated (plasma-reduced) platelet concentrates, i.e. patients with known severe allergic reactions and documented transfusion-associated circulatory overload (TACO);
- Pregnancy (or lactating);
- Prior treatment with pathogen-reduced blood products;
- Known allergy to riboflavin or its photoactive products.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanquin Research & Blood Bank Divisionslead
- Terumo BCTcollaborator
Study Sites (10)
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
Leiden University Medical Center
Leiden, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Haga Ziekenhuis
The Hague, Netherlands
Haukeland University Hospital
Bergen, Norway
Related Publications (2)
Ypma PF, van der Meer PF, Heddle NM, van Hilten JA, Stijnen T, Middelburg RA, Hervig T, van der Bom JG, Brand A, Kerkhoffs JL; PREPAReS Study Group. A study protocol for a randomised controlled trial evaluating clinical effects of platelet transfusion products: the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) trial. BMJ Open. 2016 Jan 27;6(1):e010156. doi: 10.1136/bmjopen-2015-010156.
PMID: 26817642BACKGROUNDvan der Meer PF, Ypma PF, van Geloven N, van Hilten JA, van Wordragen-Vlaswinkel RJ, Eissen O, Zwaginga JJ, Trus M, Beckers EAM, Te Boekhorst P, Tinmouth A, Lin Y, Hsia C, Lee D, Norris PJ, Goodrich RP, Brand A, Hervig T, Heddle NM, van der Bom JG, Kerkhoffs JH. Hemostatic efficacy of pathogen-inactivated vs untreated platelets: a randomized controlled trial. Blood. 2018 Jul 12;132(2):223-231. doi: 10.1182/blood-2018-02-831289. Epub 2018 May 17.
PMID: 29773572RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Louis Kerkhoffs, MD, PhD
Sanquin Blood Bank
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2016
First Posted
May 26, 2016
Study Start
November 17, 2010
Primary Completion
April 30, 2016
Study Completion
June 30, 2016
Last Updated
August 23, 2018
Record last verified: 2018-08