Photo Credit: iStock.com/gaetan stoffel
For patients with traumatic brain injury, cold-stored platelet transfusion was feasible and lowered surgical interventions, according to a recently published study.
Cold-stored platelet (CSP) transfusion for patients with traumatic brain injury (TBI) was feasible and associated with a lower rate of neurosurgical operative intervention than room temperature platelet transfusion, without an increase in adverse events, according to a study published in Annals of Surgery. However, CSP was not associated with improved 6-month Glasgow Outcome Scale-extended (GOS-E) scores, the study’s prespecified principal safety and efficacy outcome.
“Recent Food and Drug Administration (FDA) guidance allows for the use of cold-stored platelets with 14 days of storage for bleeding when conventional platelets are not available, or their use is not practical,” wrote corresponding author Jason L. Sperry, MD, MPH, of the University of Pittsburgh, and study coauthors. “Despite this recent guidance, no robust evidence demonstrates the safety and efficacy of CSPs in patients with TBI who require platelet transfusion.”
Trial Design
In the phase 2 randomized, open‑label clinical trial, the researchers allocated 100 adult patients with TBI 1:1 to receive transfusions of up to two apheresis units of either CSPs (stored ≤14 days) or standard room‑temperature platelets. The authors hypothesized that CSP transfusion would be both safe and associated with benefits in clinical outcomes.
Clinical Outcomes
According to the study, 6-month GOS-E score distributions did not differ between the CSP and room temperature platelet arms after adjusting for baseline Glasgow Coma Scale (GCS) scores.
“When the GOS-E scores were dichotomized into favorable (5 to 8) and unfavorable (1 to 4) outcomes, no significant differences were found across randomized treatment groups,” the researchers reported.
However, the findings showed that CSP transfusion yielded a clinically meaningful reduction in operative burden: the combined craniotomy/craniectomy rate was 14.4% lower than with room‑temperature platelets, a difference that persisted after controlling for initial neurologic status and time to transfusion.
Importantly, adverse‑event incidence—including thromboembolic events, transfusion reactions, and infectious complications—was comparable between groups. Furthermore, the storage age of the CSP product transfused (one to seven days compared with eight to 14 days) was not linked with differences in outcomes.
Implications & Next Steps
The findings establish CSP transfusion as feasible and surgically sparing in patients with TBI without compromising safety. Nevertheless, the absence of functional improvement on GOS‑E highlights the need for larger confirmatory trials.
“Appropriately powered phase 3 clinical trials are needed for definitive comparison to determine the safety and efficacy of CSPs in patients with TBI,” the authors concluded. “The transfusion of CSPs in TBI patients requiring platelet transfusion is feasible and has the potential to expand the available platelet supply.”
Create Post
Twitter/X Preview
Logout