Early Cold Stored Platelet Transfusion Following Traumatic Brain Injury: A Randomized Clinical Trial.

Objective: To determine the feasibility, efficacy, and safety of cold stored compared to room temperature platelet transfusion in patients with traumatic brain injury.

Summary background data: Data demonstrating the safety and efficacy of cold stored platelet transfusion are lacking following traumatic brain injury.

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 two apheresis units of cold stored platelets stored out to 14 days versus standard care room temperature 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 room temperature platelet arms (OR-1.58, 95%CI 0.71 to 3.54, P=0.27). A lower rate of neurosurgical craniotomy/craniectomy was found for those receiving cold stored platelets (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 and relevance: In brain injured patients requiring platelet transfusion, early cold stored platelet transfusion is feasible, and did not result in improved 6-month Glasgow Coma Scale-Extended scores. Early cold stored platelet transfusion was associated with a lower rate of neurosurgical operative intervention without an increase in adverse events. The storage age of the cold stored platelet product was not associated with outcome differences. Future phase 3 clinical trials are required to determine clinical outcome differences and safety attributable to cold stored platelet transfusion following traumatic brain injury.