Cold-Stored Platelets to Treat Bleeding in Cardiac Surgery Patients

Abstract

Heart disease accounts for 1 in 7 deaths in the US. When heart catheterization is not an option, heart surgery is often necessary. In total, roughly 400,000 heart surgeries are performed in the US every year. The majority of patients who undergo heart surgery require the use of a cardiopulmonary bypass pump (CPB), also known as heart-lung machine. This machine allows for oxygen-rich blood to circulate during surgery. Platelets are the major blood cells to prevent and stop bleeding. During the time on bypass pump, platelets get in contact with the plastic tubes of the machine and lose function. Patients after surgery on bypass pump are at high risk of bleeding and frequently receive transfusions of platelets to stop or reduce the bleeding. Unfortunately, room temperature-stored platelet transfusions (the current clinical standard) are of questionable value in this clinical situation. We and others have shown that storing platelets from blood donors in the refrigerator leads to better platelet function compared to storing them at room temperature (the current standard of care). We therefore would like to test if refrigerated platelets are better than room temperature-stored platelets (the current clinical standard) at stopping bleeding in cardiac surgery patients who come off bypass pump. Patients will either receive standard of care (room temperature stored platelets) or refrigerated platelets. We will test for platelet function during and after surgery and how much blood they lose through chest tube drainage, and other parameters. This will tell us if refrigerated platelets are better at reversing the platelet defect induced by the bypass pump and are better at stopping bleeding. If we find that refrigerated platelets are better at reducing or stopping blood loss, all bleeding patients could benefit from this product. We could see reduced blood loss after trauma or surgeries, shorter intensive care unit stays, shorter hospitalizations, and fewer deaths after surgeries. Of note, refrigerated platelets were routinely used in the 1960s and 1970s and there are no data to suggest that they are harmful. Studies done in test tubes suggest that they respond well to soothing reagents that are released by the vessel wall. Nevertheless, an important part of this study is to investigate if these platelets are safe and do not lead to complications. Our study will take approximately 3 years to complete. Blood banks can already get permission from the Food and Drug Administration to store platelets in the refrigerator for 3 days and give them to actively bleeding patients. But 3 days is too short and impractical, and due to a lack of proven efficacy, this has not widely been adopted. If our study shows an advantage for cold-stored platelets, this could have an immediate, practice-changing impact and improve transfusion practice for all actively bleeding patients, including Soldiers, Warfighters, military Service members, and Veterans alike. Apart from the benefit for actively bleeding patients, this study could have a marked impact on blood banking practices. Sepsis from bacteria growing in the platelet storage bag platelet is the most common cause of transfusion-transmitted infection. By storing platelets in the fridge, the risk for sepsis is markedly reduced since bacteria do not grow well at cold temperatures. Finally, storage times of cold-stored platelets could be prolonged to 15 or even 20 days greatly alleviating shortages, reducing outdates and wastage and thereby improving supply for remote civilian hospital locations and far forward military scenarios.

Document Details

Document Type
DoD Grant Award
Publication Date
Mar 15, 2021
Source ID
W81XWH2010495

Entities

People

  • Moritz Stolla

Organizations

  • Bloodworks Northwest
  • United States Army

Tags

Fields of Study

  • Medicine

Readers

  • Cardiovascular Physiology
  • Trauma Surgery or Emergency Medicine.