Improving efficacy and safety of pathogen inactivation strategies for platelet transfusion
Anonymous (not verified)
Wed, 01/19/2022 – 07:50
CERSI Collaborators: Magali Fontaine, MD, PhD
FDA Collaborators: Carlos H. Villa, MD, PhD, CD Atreya, PhD
Project Start Date: September 1, 2019
Regulatory Science Challenge
Platelets, a type of blood cell, 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 decrease that risk. The FDA guidance “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion” (https://www.fda.gov/media/123448/download) describes several strategies for control of bacterial risk in platelets, including the use of FDA approved devices that reduce pathogens such as bacteria and viruses. Currently approved pathogen reduction methods involve incubation of the platelet bag with a chemical and illumination of the bag with ultraviolet light. This treatment is intended to inactivate any potential pathogens in the platelet bag, but can also have effects on the platelets. Clinical data with pathogen reduced platelets to date are largely focused on their use to prevent bleeding in patients with low platelet counts. More data are needed on the hemostatic activity of pathogen reduced platelets in the actively bleeding patient.
Project Description and Goals
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.
FDA – WEB CONTENT MANAGEMENT SYSTEM