Early Cold Stored Platelet Transfusion Following Severe Injury

Early Cold Stored Platelet Transfusion Following Severe Injury

26 November 2024

Early platelet transfusion is an integral element of trauma resuscitation. In the United States, recent Food and Drug Administration (FDA) guidance permits the use of cold stored platelets, with a shelf life of 14 days, to treat active bleeding when standard room temperature platelets are unavailable, or their use is not practical.   

The Cold Stored Platelet for Hemorrhagic Shock (CriSP-HS) study was a phase 2, multicentre, open label, randomised clinical trial that compared outcomes in patients at risk for haemorrhagic shock receiving cold stored platelets (CSPs) transfusion and concomitant standard care resuscitation versus standard care resuscitation alone. At the five participating US level 1 trauma centres, the intervention arm received a single apheresis unit of urgent release CSPs which was transfused as soon as feasible, while concomitant standard care resuscitation was occurring. The primary outcome for the trial was feasibility whilst the prespecified principal outcome for assessing safety and efficacy for the trial was 24-hour mortality.    

In 2022 and 2023, a total of 200 patients were randomised constituting the intent-to-treat cohort. Mortality at 24 hours was 5.9% (6/102) in patients randomised to early cold stored platelet transfusion and 10.2% (10/98) in the standard care arm, which did not reach statistical significance (difference, −4.3%; 95% CI, −12.8% to 3.5%; P=0.26). Regarding the secondary clinical outcomes, no group differences were found in 3-hour mortality, in-hospital mortality or 30-day mortality. In addition, no significant differences were found in the occurrence of death due to haemorrhage, the incidence of ARDS or in the incidence of arterial or venous thromboembolic events. With regard to the total number of adverse events and serious adverse events, these were similar across both arms. Lastly, after accounting for confounders via propensity score adjustment, the storage age of the cold stored platelet product transfused was not associated with 24-hour mortality (adjusted odds ratio, 1.4; 95% CI, 0.12–17.6; P= 0.77).   

Based on these findings, the authors concluded that the early transfusion of one apheresis unit of cold stored platelets is feasible and safe. Phase 3 clinical trials are needed, appropriately powered for clinical outcomes. The utility of this blood component has the potential to expand the available platelet supply to treat bleeding.   

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