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Clinical Trial
. 2024 Aug 1;280(2):212-221.
doi: 10.1097/SLA.0000000000006317. Epub 2024 May 6.

Early Cold Stored Platelet Transfusion Following Severe Injury: A Randomized Clinical Trial

Jason L Sperry  1 , Francis X Guyette  2 , Bedda L Rosario-Rivera  3 , Matthew E Kutcher  4 , Lucy Z Kornblith  5 , Bryan A Cotton  6 , Chad T Wilson  7 , Kenji Inaba  8 , Eva V Zadorozny  2 , Laura E Vincent  9 , Ashley M Harner  9 , Emily T Love  9 , Joseph E Doherty  4 , Joseph Cuschieri  5 , Aaron E Kornblith  10 , Erin E Fox  6 , Yu Bai  6 , Marcus K Hoffman  7 , Catherine P Seger  7 , Jay Hudgins  8 , Sheila Mallett-Smith  8 , Matthew D Neal  1 , Christine M Leeper  1 , Philip C Spinella  1 , Mark H Yazer  11 , Stephen R Wisniewski  3 ; Cold Stored Platelet for Hemorrhagic Shock (CRISP-HS) Study Group
Affiliations
Clinical Trial

Early Cold Stored Platelet Transfusion Following Severe Injury: A Randomized Clinical Trial

Jason L Sperry et al. Ann Surg. .

Abstract

Objective: To determine the feasibility, efficacy, and safety of early cold stored platelet transfusion compared with standard care resuscitation in patients with hemorrhagic shock.

Background: Data demonstrating the safety and efficacy of early cold stored platelet transfusion are lacking following severe injury.

Methods: A phase 2, multicenter, randomized, open label, clinical trial was performed at 5 US trauma centers. Injured patients at risk of large volume blood transfusion and the need for hemorrhage control procedures were enrolled and randomized. The intervention was the early transfusion of a single apheresis cold stored platelet unit, stored for up to 14 days versus standard care resuscitation. The primary outcome was feasibility and the principal clinical outcome for efficacy and safety was 24-hour mortality.

Results: Mortality at 24 hours was 5.9% in patients who were randomized to early cold stored platelet transfusion compared with 10.2% in the standard care arm (difference, -4.3%; 95% CI, -12.8% to 3.5%; P =0.26). No significant differences were found for any of the prespecified ancillary outcomes. Rates of arterial and/or venous thromboembolism and adverse events did not differ across treatment groups.

Conclusions and relevance: In severely injured patients, early cold stored platelet transfusion is feasible, safe and did not result in a significant lower rate of 24-hour mortality. Early cold stored platelet transfusion did not result in a higher incidence of arterial and/or venous thrombotic complications or adverse events. The storage age of the cold stored platelet product was not associated with significant outcome differences.

Trial registration: ClinicalTrials.gov identifier: NCT04667468.

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Conflict of interest statement

J.L.S. reports grants from the DoD; F.X.G. reports grants from the DoD; S.R.W. reports grants from the DoD; L.Z.K. reports grants and consulting fees from University of Maryland/BARDA, personal fees from Gamma Diagnostics, Coagulant Therapeutics, Haemonetics, other from Cerus, outside the submitted work; A.E.K. reports being founder of CaptureDx; J.C. reports participates on the steering committee for Faraday Pharmaceuticals; M.D.N. has received grants from National Institutes of Health, Department of Defense, DARPA, Haemonetics, Alexion and Instrumentation Laboratories, honoraria for lectures from Haemonetics and Takeda, support for attending meetings and/or travel from Takeda; participates on a Data Safety Monitoring Board or Advisory Board from NHLBI CONNECTS Steering Committee; is the Chief Medical Officer, Haima Therapeutics, and has Patents planned, issued or pending (US Patent 11,408.844; US Patent 9.072,760), outside the submitted work; P.C.S. reports personal fees from Hemanext, Cerus, participates in advisory board for Octapharma,and Haima, and is the Co-Founder and Chief Medical Officer of Kalocyte, outside the submitted work. The remaining authors report no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Flow of patients in the cold stored platelets in hemorrhagic shock (CRISP-HS) trial. Screening, randomization, and follow-up of the study participants. All data and events before refusal of consent for continued participation were included in clinical outcome comparisons.
FIGURE 2
FIGURE 2
Kaplan-Meier survival analysis at 24-hour postrandomization.
FIGURE 3
FIGURE 3
Subgroup analysis for 24-hour mortality. A, Differences in 24-hour mortality in the 4 prespecified subgroups. B, Twenty-four hour mortality differences with CIs. The black circles represent the difference in 24-hour mortality and horizontal bars represent the 95% CI. The difference was computed as 24-hour mortality for CSP minus 24-hour mortality for SC. The 95% CIs are exact (Clopper-Pearson) confidence limits. The gray dashed vertical line represents a difference in 24-hour mortality of 0, indicating no difference in 24-hour mortality between CSP and SC treatment arms. P-values are for the interaction term between treatment arms and subgroup in a logistic regression model with 24-hour mortality as the outcome. CSP indicates cold stored platelets; SC, standard care; MT, massive transfusion; TBI, traumatic brain injury.
See this image and copyright information in PMC

References

    1. Cannon JW. Hemorrhagic shock. N Engl J Med. 2018;378:370–379. - PubMed
    1. Davis JS, Satahoo SS, Butler FK, et al. An analysis of prehospital deaths: Who can we save? J Trauma Acute Care Surg. 2014;77:213–218. - PubMed
    1. Eastridge BJ, Mabry RL, Seguin P, et al. Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg. 2012;73(suppl 5):S431–S437. - PubMed
    1. Rhee P, Joseph B, Pandit V, et al. Increasing trauma deaths in the United States. Ann Surg. 2014;260:13–21. - PubMed
    1. Guyette FX, Brown JB, Zenati MS, et al. Tranexamic acid during prehospital transport in patients at risk for hemorrhage after injury: a double-blind, placebo-controlled, randomized clinical trial. JAMA Surg. 2020;156:11–20. - PMC - PubMed

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