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