Re-analysis of the PolyHeme Phase III trial dataset: Lessons for future haemoglobin-based oxygen carrier trauma trials

•New analyses of the PolyHeme Phase III clinical trial database examined adverse early outcomes versus original 30-day mortality; amongst 714 trauma patients, adverse event reporting showed coagulopathy was significantly more frequent after PolyHeme administration than blood in the first 12 h; 10 more liters of fluid were administered during initial resuscitation of 55 patients with major haemorrhage randomized to PolyHeme; nadir total haemoglobin [THb] < 6 g/dl was correlated with increased mortality on Day 1 after PolyHeme; future trials should use HBOC with higher haemoglobin concentration, lower volume and transition to blood plus coagulation factors or whole blood.