The PREPAReS Study: Pathogen Reduction Evaluation & Predictive Analytical Rating Score.
Recruiting
- Conditions
- Bleeding Grade 2-4 transfusionpathogen reductionthrombocytes
- Registration Number
- NL-OMON21216
- Lead Sponsor
- CaridianBCT Biotechnologies LLC Sanquin Blood supply
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 618
Inclusion Criteria
1. Age ≥ 18 years;
2. Expected ≥ 2 platelet transfusion requirements;
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);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method WHO grade ≥ 2 bleeding complications of PCs.
- Secondary Outcome Measures
Name Time Method sing PCs, stored for 1-7 days:<br /><br>1. The 1 and 24 hour CI;<br /><br>2. The 1 and 24 hour CCI;<br /><br>3. (1+24 hour CCI)/2;<br /><br>4. Adverse transfusion reactions;<br /><br>5. Total transfusion requirement of red cells and platelets;<br /><br>6. Platelet transfusion interval;<br /><br>7. Rate of HLA allo-immunization;<br /> <br>8. In vitro quality markers related with the 1-hour or 24-hour CCI;<br /><br>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.<br>