PRBCs, LyoPlas Not Superior to Sodium Chloride to Treat Trauma-Related Hemorrhagic Shock

Pre-hospital administration of packed red blood cells (PRBC) and lyophilized plasma (LyoPlas) does not appear to be superior to 0.9% sodium chloride for the treatment of trauma-related hemorrhagic shock, according to new findings published in The Lancet Haematology.

In the “Resuscitation with pre-hospital blood products” (RePHILL) trial, investigators randomized 432 adult patients with trauma-related hemorrhagic shock and hypotension to receive either PRBC and LyoPlas (up to two units each) or up to one liter of 0.9% sodium chloride over four 250 ml boluses. A total of 209 patients received PRBC and LyoPlas, while 223 patients received 0.9% sodium chloride. The primary outcome was a composite of episode mortality or impaired lactate clearance, or both, measured in the intention-to-treat population. The median follow-up for all 432 participants was 8 days.

The primary outcome occurred in 64% of patients in the PRBC–LyoPlas group and in 65% of patients in the 0.9% sodium chloride group (adjusted risk ratio 1.01). The rates of transfusion-related complications within 24 hours of arrival in the emergency department were similar for both treatment groups (7% in the PRBC–LyoPlas group and 7% in the 0.9% sodium chloride group, adjusted relative risk 1.05). Six percent of patients in PRBC–LyoPlas group and 2% of patients in the 0.9% sodium chloride group experienced acute respiratory distress syndrome. There were no treatment-related deaths.

Upon arrival to the hospital, the mean hemoglobin concentration was higher in the PRBC–LyoPlas group than in the 0.9% sodium chloride group (133 grams per liter versus 118 g/L). Blood product use was similar after hospital admission up to 24 hours; however, a post-hoc analysis found that total blood and plasma use was higher in the PRBC–LyoPlas group (an average of 6.34 PRBC units and 5.04 plasma units in the PRBC/LyoPlas group compared with 4.41 PRBC units and 3.37 plasma units in the 0.9 sodium chloride group). According to investigators, the results suggest that the logistical and financial costs of bringing blood product resuscitation forward from hospital to the pre-hospital domain “might not be routinely justified within the context of a modern major trauma network.”

Investigators noted several explanations as to why RePHILL did not demonstrate benefit from pre-hospital blood products while some military and civilian studies suggest that early transfusion improves survival. For example, investigators cited that the study took place in a civilian setting within an established major trauma network, where pre-hospital critical care is provided at the scene of the incident by critical care practitioners and doctors. Additionally, a proportion of study participants had transport times of less than 20 minutes. Other studies suggest this group might not benefit from pre-hospital transfusion.

According to the authors, additional variables that require future study include the use of lyophilized versus fresh frozen plasma (FFP), the plasma-to-PRBC transfusion ratio, the addition of coagulation factors or platelets, and the use the of whole blood. Based on current evidence, the investigators concluded that the decision to commit to routine pre-hospital transfusion in civilian practice will require careful consideration by all stakeholders.

In response to the findings, AABB’s Chief Medical Officer Claudia S. Cohn, MD, PhD, hailed the study as an important step forward in our understanding of pre-hospital patient support and agreed that additional research is necessary. 

“It is difficult to extend findings from the military theater to an urban setting, but studies such as RePHILL help to bridge this gap in our knowledge,” Cohn said. “In light of ongoing blood supply pressures, these findings help health care providers identify which patients may not benefit from pre-hospital transfusion.”