CERSI P.I. and Collaborator: Magali Fontaine, M.D., Ph.D.
FDA SME and Collaborator: Carlos H. Villa, M.D., Ph.D., CBER
Project Overview
Platelets are used to treat or prevent bleeding. Because platelets are usually stored at room temperature, they are associated with a higher risk of bacterial contamination compared to other blood products. Blood collection establishments and transfusion services must take measures to mitigate that risk. One of these measures can be the use of pathogen-reduced platelet products. Currently approved pathogen reduction methods involve incubation of the platelet bag with a chemical and illumination of the bag with ultra violet light. This treatment is intended to inactivate any potential pathogens in the platelet bag. This study will evaluate how well pathogen reduced platelets control bleeding when many blood products are needed to stop active bleeding. Specifically, the current study will evaluate how well pathogen treated platelets restore platelet function and control bleeding in patients undergoing open heart surgery on cardiopulmonary bypass. Cardiopulmonary bypass alters platelet function and the transfusion of functional platelets, together with other blood products, is often required to control bleeding post-operatively. The efficiency of patients’ blood coagulation will be compared in patients who received either a pathogen-reduced platelet product or a conventional platelet product.
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