Annals of surgery · 2025
Early Cold-stored Platelet Transfusion following Traumatic Brain Injury: A Randomized Clinical Trial.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Neal Matthew D, Okonkwo David O, Guyette Francis X, Luther James F, Vincent Laura E, Puccio Ava M, Harner Ashley M, Agnone Allison G, Brubaker Donovan P, Love Emily T, Leeper Christine M, Brown Joshua B, Forsythe Raquel, Spinella Philip C, Yazer Mark H, Wisniewski Stephen R, Sperry Jason L, the Cold Stored Platelet for Traumatic Brain Injury (CRISP-TBI) study group
Аннотация
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.
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.