The PREPAReS Study: Pathogen Reduction Evaluation & Predictive Analytical Rating Score.

Official Title

Clinical effectiveness of standard versus pathogen-reduced buffy coat-derived platelet concentrates in plasma in hemato oncological patients.

Summary:

The study is a prospective, randomized multicenter trial for the evaluation of platelet products in hemato oncological patients with thrombocytopenia or expected to become thrombocytopenic caused by myelosuppressive therapy or malignancy-related myelosuppression. In this trial patients will be randomized to receive one of two platelet products during a transfusion episode with a maximum of 6 weeks. Because the Mirasol-treated platelet products show a color difference not allowing an appropriate placebo, the study will be single-blinded for investigators evaluating the bleeding score.
Products will be stored up to 7 days. The primary endpoint is restricted to 5 days storage as this implies the most relevant information. Secondary endpoint evaluation requires that the patient continues treatment in the assigned study arm.Arm A: Plasma stored platelet concentrates (Plasma-PCs);Arm B: Pathogen reduced plasma-stored platelet concentrates (PR-plasma-PCs).

Trial Description

Primary Outcome:

  • WHO grade ≥ 2 bleeding complications of PCs
Secondary Outcome:
  • Using PCs, stored for 1-7 days:
  • 1. The 1 and 24 hour CI;
  • 2. The 1 and 24 hour CCI;
  • 3. (1+24 hour CCI)/2;
  • 4. Adverse transfusion reactions;
  • 5. Total transfusion requirement of red cells and platelets;
  • 6. Platelet transfusion interval;
  • 7. Rate of HLA allo-immunization;
  • 8. In vitro quality markers related with the 1-hour or 24-hour CCI;
  • 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.

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society