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.
The study revealed the following findings:
- Participants were mostly white (62%) and male (82%), had a median age of 38 years, and were mostly involved in a road traffic collision (62%) with severe injuries (median injury severity score 36).
- Before randomization, participants had received on average 430 mL crystalloid fluids and tranexamic acid (90%).
- The composite primary outcome occurred in 128 (64%) of 199 participants randomly assigned to PRBC–LyoPlas and 136 (65%) of 210 randomly assigned to 0·9% sodium chloride (adjusted risk difference –0·025%).
- The rates of transfusion-related complications in the first 24 h after ED arrival were similar across treatment groups (PRBC–LyoPlas 11 [7%] of 148 compared with 0·9% sodium chloride nine [7%] of 137, adjusted relative risk 1·05).
- Serious adverse events included acute respiratory distress syndrome in nine (6%) of 142 patients in the PRBC–LyoPlas group and three (2%) of 130 in 0·9% sodium chloride group, and two other unexpected serious adverse events, one in the PRBC-LyoPlas (cerebral infarct) and one in the 0·9% sodium chloride group (abnormal liver function test). There were no treatment-related deaths.
"This phase 3, multicentre, randomized controlled superiority trial did not show that prehospital PRBC–LyoPlas resuscitation was superior to 0·9% sodium chloride for trauma-related hemorrhagic shock in the civilian population studied," wrote the authors.
"Although the point estimate for the individual components of the primary outcome and some of the secondary outcomes point towards potential benefit from an allocation to PRBC–LyoPlas, the confidence intervals indicate the possibility of both harm and benefit."
Reference:
The study titled, "Resuscitation with blood products in patients with trauma-related haemorrhagic shock receiving prehospital care (RePHILL): a multicentre, open-label, randomised, controlled, phase 3 trial," was published in The Lancet Haematology.
DOI: https://doi.org/10.1016/S2352-3026(22)00040-0
Keywords: Lancet, trauma, hemorrhagic shock, prehospital care, Nicholas Crombie, packed red blood cells, lyophilized plasma, resuscitation, sodium chloride, blood products, plasma, rbc, red blood cells, severe injuries, road accidents
