The first randomized trial of human polymerized hemoglobin as a blood substitute in acute trauma and emergent surgery

Background: Human polymerized hemoglobin (PolyHeme) is a universally compatible, disease-free, oxygen-carrying resuscitative fluid. This is the first prospective, randomized trial to compare directly the therapeutic benefit of PolyHeme with that of allogeneic red blood cells (RBCs) in the treatment of acute blood loss. Study Design: Forty-four trauma patients (33 male, 11 female) aged 19-75 years with an average Injury Severity Score (ISS) score of 21 +/- 10 were randomized to receive red cells (n = 23) or up to 6 U (300 g) of PolyHeme (n = 21) as their initial blood replacement after trauma and during emergent operations. Results: There were no serious or unexpected adverse events related to PolyHeme. The PolyHeme infusion of 4.4 +/- 2.0 units (mean +/- SD) resulted in a plasma [Hb] of 3.9 +/- 1.3 g/dL, which accounted for 40% of the total circulating [Hb]. There was no difference in total [Hb] between the groups before infusion (10.4 +/- 2.3 g/dL control vs. 9.4 +/- 1.9 g/dL experimental). At end-infusion the experimental RBC [Hb] fell to 5.8 +/- 2.8 g/dL vs. 10.6 +/- 1.8 g/dL (p < 0.05) in the control, although the total [Hb] was not different between the groups or from pre-infusion. The total number of allogeneic red cell transfusions for the control and experimental groups was 10.4 +/- 4.2 units vs. 6.8 +/- 3.9 units (p < 0.05) through day 1, and 11.3 +/- 4.1 units vs. 7.8 +/- 4.2 units (p = 0.06) through day 3. Conclusions: PolyHeme is safe in acute blood loss, maintains total [Hb] in lieu of red cells despite the marked fall in RBC [Hb], and reduces the use of allogeneic blood. PolyHeme appears to be a clinically useful blood substitute. (J Am Coll Surg 1998;187:113-122. (C) 1998 by the American College of Surgeons)