Cold-Stored Platelets to Treat Bleeding in Cardiac Surgery Patients
Abstract
The objective of this clinical trial is to assess the feasibility of the study protocol and preliminarily test the efficacy and safety of platelets stored at cold conditions (1-6C) in 100% plasma for 10-14 days (CSP) in cardiac surgery patients who are actively bleeding and require platelet transfusion. The control treatment arm will receive platelets stored at room temperature (20-24C)in 100% plasma (RSP) for up to 7 days. In this preliminary study, we are also clarifying critical mechanistic questions related to the nature of the platelet defect in the patient population under study and the post-transfusion function of stored platelets utilizing specialized laboratory assays. We hypothesize that 1) CSP are more effective than RSP at reducing blood loss and improving platelet function in subjects actively bleeding due to cardiac surgery with cardiopulmonary bypass (CPB), and that 2)CSP are safe and do not lead to increased risks relative to RSP. The overarching goal of our investigations is to evaluate the role of cold stored platelets for any actively bleeding subject with a potential platelet defect, including trauma subjects. If our hypotheses can be supported by data, our study, together with larger follow-on studies, could have a practice-changing impact.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2022
- Accession Number
- AD1192030
Entities
People
- Mortiz Stolla
- Patricia Klotz
Organizations
- Bloodworks Northwest