Question and Methods: Pragmatic, European, multi-center RCT comparing outcomes in trauma patients who received empiric massive transfusion protocols (MTPs) augmented either by viscoelastic hemostatic assays (VHAs) or conventional coagulation test (CCT)-guided intervention.
Findings: Primary outcome – at 24h, no difference in the proportion of patients who were alive and free of massive transfusion between groups. No differences in any secondary outcomes. In the pre-specified subgroup with TBI, mortality benefit at 28d in the VHA-guided group
Limitations: Less coagulopathy than expected, lower observed vs predicted effect size in primary outcome – possibly under-powered. Empiric administration of 1:1:1 blood products in both arms and the lack of a sequential VHA algorithm might have masked benefits. No comment on surgical sources of bleeding and if these were corrected.
Interpretation: First larger-scale RCT comparing VHA (both TEG and ROTEM) to CCT-guided MTP. Study findings suggest that all-comers do not benefit from VHA-guided MTPs though limitations dampen this statement. Future study should test a stepwise VHA protocol and identify injury types that may benefit from a VHA-guided approach, e.g. severe TBI.