Prehospital transfusion not superior to 0.9 percent sodium chloride for trauma-related haemorrhagic shock: Lancet

UK: Findings from a phase 3 trial showed that prehospital packed red blood cells (PRBC)-lyophilized plasma (LyoPlas) resuscitation is not superior to 0·9% sodium chloride for adult patients with trauma-related hemorrhagic shock. The results, published in The Lancet Haematology, suggest that decision to perform routine prehospital transfusion will require careful deliberation by all stakeholders. 

"There is a need for further research to identify the characteristics of patients in whom prehospital transfusion might be beneficial and to identify the optimal outcomes for transfusion trials in major trauma," Nicholas Crombie, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK, and colleagues wrote in their study. 

Changes in the trauma resuscitation practice during the past two decades have seen substantial changes. much of which has been influenced by lessons learned during conflicts. Now, the treatment of hemorrhagic shock is increasingly being focused on the early use of tranexamic acid, hemorrhage control, and blood-based resuscitation with packed red cells and plasma. In the military and civilian settings, the improved survival from these and other strategies within streamlined trauma systems has been stimulated and has stimulated an interest in prehospital transfusion.

Time to treatment matters in traumatic hemorrhage but there is no certainty on the optimal prehospital use of blood in major trauma. Dr. Crombie and the team, therefore, aimed to investigate whether the use of packed red blood cells and lyophilized plasma is superior to the use of 0·9% sodium chloride for improving tissue perfusion and reducing mortality in trauma-related hemorrhagic shock in Resuscitation with pre-hospital blood products (RePHILL) -- a multicentre, allocation concealed, open-label, parallel-group, randomized, controlled, phase 3 trial. 

RePHILL trial was done in four civilian prehospital critical care services in the UK. Adults (age ≥16 years) with trauma-related hemorrhagic shock and hypotension were assessed for eligibility. Eligible (n=432 participants were then randomly assigned to receive either up to two units each of PRBC and LyoPlas (n=209) or up to 1 L of 0·9% sodium chloride (n=223) administered through the intraosseous or intravenous route. 

Sealed treatment packs that were similar in external appearance, containing PRBC–LyoPlas or 0·9% sodium chloride were prepared by blood banks and issued to participating sites according to a randomization schedule prepared by the coordinating center (1:1 ratio, stratified by site). A composite of episode mortality or impaired lactate clearance, or both, measured in the intention-to-treat population was the primary outcome. 

Due to disruption caused by the COVID-19 pandemic, trial recruitment was stopped before it achieved the intended sample size of 490 participants. The median follow-up was 9 days (IQR 1 to 34) for participants in the PRBC–LyoPlas group and 7 days (0 to 31) for people in the 0·9% sodium chloride group.