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Efficacy Data Show Potential for Dual Inventory With Cold-, Room Temperature-Stored Platelet Transfusions

April 9, 2024

May 2024

Katie Robinson

Katie Robinson is a medical writer based in New York.

The transfusion of cold-stored platelets (CSP) in plasma increased thrombin generation in healthy volunteer recipients but did not activate integrin. This is according to a small study published in Blood, which also suggested that it is possible to identify ideal donors of room temperature-stored platelets (RSP) and CSP.1

“Our study provides the groundwork for understanding how platelets work after cold or room temperature storage in recipients,” said Moritz Stolla, MD, PhD, of Bloodworks Northwest Research Institute and the University of Washington in Seattle. “Unexpectedly, we found that the two storage temperatures promote different aspects of platelets’ contribution to hemostasis. Larger, randomized, controlled trials are needed to confirm that CSPs reduce blood loss in bleeding patients.”

In June 2023, the U.S. Food and Drug Administration (FDA) allowed blood banks to manufacture and transfuse CSPs stored up to 14 days to actively bleeding patients if RSPs are unavailable or impractical.2 Despite lacking post-transfusion data, the FDA made the decision because of shortages with five- to seven-day RSPs, which is the current gold standard.1

“In this study, we tested the platelet quality at room temperature and CSPs stored to their maximum storage time. We tested the aggregation and procoagulant function of autologous platelets in healthy humans on aspirin,” Dr. Stolla said.

This randomized crossover trial compared the post-transfusion hemostatic function of seven-day RSPs with 14-day CSPs — the maximum approved storage times — in nine healthy volunteers (aged 18-59). The participants ingested acetylsalicylic acid (ASA) antiplatelet therapy and donated one platelet unit, randomly stored at 22°C or 4°C. The recipients and storage bags were tested for the lipid mediators lysoglycerophospholipids, oxylipins, and polyunsaturated fatty acids (PUFAs). The primary endpoint was platelet aggregation in whole blood at one hour post-transfusion to measure the reversal of ASA by platelet transfusion. The researchers also considered tests of platelet function and hemostasis, along with analyses of microparticles and lipidomics.

For the primary endpoint, RSP transfusion improved platelet function as measured by VerifyNow ASA at one hour post-transfusion (p=0.0055). RSP transfusion improved platelet function at 24 hours but not at four hours after transfusion, compared with CSPs, which failed to overcome the effect of ASA at any time. However, CSP transfusion led to greater thrombin generation, independent of platelet microparticles. Levels of lyso platelet-activating factor species predicted the procoagulant capacity of CSPs, while PUFA concentrations predicted the aggregation response of RSPs.

“While room temperature storage is better for preserving platelet aggregation, cold storage for 14 days leads to more thrombin generation in the recipients. We also show that some platelet markers in the storage bag help to identify whether platelets from a specific donor are more suitable for room temperature or cold storage,” Dr. Stolla said.

The low number of participants was a limitation of the study, but the authors noted that the crossover design eliminated any between-participant variability. Another limitation was that the researchers investigated autologous CSPs in healthy individuals, and they suggested that randomized clinical trials in patients with cancer, trauma, or those undergoing surgery are needed to confirm the results.

“In the future, blood banks could have a dual inventory with RSPs for prophylactic transfusions, for example, in hematology/oncology patients, and CSPs for bleeding surgery and trauma patients,” Dr. Stolla said. “This approach could preserve platelet inventories and alleviate platelet shortages.”

Any conflicts of interest declared by the authors can be found in the original article.

References

  1. Kogler VJ, Miles J, Ozpolat T, et al. Platelet dysfunction reversal with cold-stored vs. room temperature-stored platelet transfusions [published online ahead of print, 2024 March 1]. Blood. doi: 10.1182/blood.2023022593.
  2. U.S. Food and Drug Administration. Alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical. June 23, 2023. Accessed March 18, 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/alternative-procedures-manufacture-cold-stored-platelets-intended-treatment-active-bleeding-when.

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