Status:
COMPLETED
Pathogen Reduction Evaluation & Predictive Analytical Rating Score
Lead Sponsor:
Sanquin Research & Blood Bank Divisions
Collaborating Sponsors:
Terumo BCT
Conditions:
Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
Currently some pathogen-reduced platelet products (PR-PCs) have passed phase III studies, are in progress or can be expected in the near future. At present some transfusion centers throughout Europe h...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 17 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2016
Estimated Enrollment :
567 Patients enrolled
Trial Details
Trial ID
NCT02783313
Start Date
November 17 2010
End Date
June 30 2016
Last Update
August 23 2018
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
McMaster University
Hamilton, Canada
2
Kingston General Hospital
Kingston, Canada
3
London Health Sciences Centre
London, Canada
4
Ottawa Hospital
Ottawa, Canada