Clinical effectiveness of standard versus pathogen-reduced buffy coat-derived platelet concentrates in plasma in hemato-oncological patients;Pathogen Reduction Evaluation & Predictive Analytical Rating Score (The PREPAReS Study)
- Conditions
- 10047075bleeding10035534Thrombocytopenia
- Registration Number
- NL-OMON43833
- Lead Sponsor
- Sanquin bloedvoorziening
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
* Age * 18 years.
* Expected * 2 platelet transfusion requirements.
* Having a hemato-oncological disease
* 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>bleeding</p><br>
- Secondary Outcome Measures
Name Time Method <p>platelet increments after transfusion, including correction for the body<br /><br>surface area<br /><br>percentage days with bleeding<br /><br>transfusion reactions<br /><br>number of red cell transfusions and platelet transfusions<br /><br>number of days between transfusions<br /><br>percentage of patients that develop antibodies<br /><br>relation between laboratory tests and clinical outcomes<br /><br>clinical factors that have an interaction with blood coagulation</p><br>