Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 May 1;281(5):796-805.
doi: 10.1097/SLA.0000000000006640. Epub 2025 Jan 22.

Early Cold-stored Platelet Transfusion following Traumatic Brain Injury: A Randomized Clinical Trial

Matthew D Neal  1 , David O Okonkwo  2 , Francis X Guyette  3 , James F Luther  4 , Laura E Vincent  5 , Ava M Puccio  2 , Ashley M Harner  5 , Allison G Agnone  2 , Donovan P Brubaker  5 , Emily T Love  5 , Christine M Leeper  1 , Joshua B Brown  1 , Raquel Forsythe  1 , Philip C Spinella  1 , Mark H Yazer  6 , Stephen R Wisniewski  4 , Jason L Sperry  1 ; and the Cold Stored Platelet for Traumatic Brain Injury (CRISP-TBI) study group
Collaborators, Affiliations
Clinical Trial

Early Cold-stored Platelet Transfusion following Traumatic Brain Injury: A Randomized Clinical Trial

Matthew D Neal et al. Ann Surg. .

Abstract

Objective: To determine the feasibility, efficacy, and safety of cold storage compared with room temperature (RT) platelet transfusion in patients with traumatic brain injury (TBI).

Background: Data demonstrating the safety and efficacy of cold-stored platelet (CSP) transfusion are lacking after TBI.

Methods: A phase 2, randomized, open-label clinical trial was performed at a single U.S. trauma center. Traumatic brain-injured patients with positive brain imaging and a need for platelet transfusion received up to 2 apheresis units of CSPs stored out to 14 days versus standard care RT platelet transfusion. The primary outcome was feasibility and the principal clinical outcome for efficacy and safety was the 6-month Glasgow Coma Scale-extended score.

Results: The 6-month Glasgow Outcome Scale-extended score distributions were not different across cold stored and RT platelet arms (odds ratio: 1.58, 95% CI: 0.71 to 3.54, P = 0.27). A lower rate of neurosurgical craniotomy/craniectomy was found for those receiving CSPs (difference: -14.4%, 95% CI: -26.5% to -2.3%, P = 0.03). Adverse event rates did not differ across groups. The storage age of the cold-stored product was not associated with outcome differences.

Conclusions: In brain-injured patients requiring platelet transfusion, early CSP transfusion is feasible and did not result in improved 6-month Glasgow Coma Scale-extended scores. Early CSP transfusion was associated with a lower rate of neurosurgical operative intervention without an increase in adverse events. The storage age of the CSP product was not associated with outcome differences. Future phase 3 clinical trials are required to determine clinical outcome differences and safety attributable to CSP transfusion after TBI.

Keywords: antiplatelet medication; cold-stored platelets; randomized; traumatic brain injury.

PubMed Disclaimer

Conflict of interest statement

M.D.N. has received grants from the 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. D.O.O. reports funding from NIH, DoD, and Abbott. F.X.G. reports grants from the DoD. 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. S.R.W. reports grants from the DoD. J.L.S. reports grants from the DoD. The remaining authors report no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Flow of patients in the CriSP-TBI 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
Prespecified subgroup analysis for 6-month GOS-E.
FIGURE 3
FIGURE 3
Randomized group comparison for neurosurgical operative intervention (craniotomy/craniectomy). A cumulative incidence function was estimated for time to craniectomy/craniotomy to account for death being a competing risk.
See this image and copyright information in PMC

References

    1. Guan B, Anderson DB, Chen L, et al. . Global, regional and national burden of traumatic brain injury and spinal cord injury, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. BMJ Open. 2023;13:e075049. - PMC - PubMed
    1. Waltzman D, Haarbauer-Krupa J, Womack LS. Traumatic brain injury in older adults—a public health perspective. JAMA Neurol. 2022;79:437–438. - PMC - PubMed
    1. Shaik NF, Law CA, Elser H, et al. . Trends in traumatic brain injury mortality in the US. JAMA Neurol. 2024;81:194–195. - PMC - PubMed
    1. Maas AIR, Menon DK, Manley GT, et al. . Traumatic brain injury: progress and challenges in prevention, clinical care, and research. Lancet Neurol. 2022;21:1004–1060. - PMC - PubMed
    1. Santos-Lozada AR. Trends in deaths from falls among adults aged 65 years or older in the US, 1999-2020. JAMA. 2023;329:1605–1607. - PMC - PubMed

Publication types