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Randomized Controlled Trial
. 2018 Sep;58(9):2129-2138.
doi: 10.1111/trf.14780.

Safety and Efficacy of Cryopreserved Platelets in Bleeding Patients With Thrombocytopenia

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Randomized Controlled Trial

Safety and Efficacy of Cryopreserved Platelets in Bleeding Patients With Thrombocytopenia

Sherrill J Slichter et al. Transfusion. .

Abstract

Background: The short dating period of room temperature-stored platelets (PLTs; 5-7 days) limits their availability at far-forward combat facilities and at remote civilian sites in the United States. PLT cryopreservation in 6% DMSO and storage for up to 2 years may improve timely availability for bleeding patients.

Study design and methods: A dose escalation trial of DMSO-cryopreserved PLTs (CPPs) compared to standard liquid-stored PLTs (LSPs) was performed in bleeding patients with thrombocytopenia. Within each of four cohorts, six patients received escalating doses of CPP (0.5 unit, 1 unit, and sequential transfusions of 2 and 3 units) and one received a LSP transfusion. Patients were monitored for adverse events (AEs), coagulation markers, PLT responses, and hemostatic efficacy.

Results: Patients with a World Health Organization bleeding score of 2 or more received from 0.5 to 3 units of CPP (n = 24) or 1 unit of LSP (n = 4). There were no related thrombotic or other serious AEs experienced. Mild transfusion-related AEs of chills and fever (n = 1), transient increased respiratory rate (n = 1), DMSO-related skin odor (n = 2), and headache (n = 1) were observed after CPP transfusion. Among CPP recipients 14 of 24 (58%) had improved bleeding scores, including three of seven (43%) patients who had intracerebral bleeding. CPP posttransfusion PLT increments were significantly less than those of LSPs; however, days to next transfusion were the same. After transfusion, the CPP recipients had improvements in some variables of thrombin generation tests and thromboelastography.

Conclusion: Cryopreserved PLT transfusions appear to be safe and effective when given to bleeding patients with thrombocytopenia.

Trial registration: ClinicalTrials.gov NCT02078284.

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