Small study of data collected more than 15 years ago suggests hemoglobin-based oxygen carrier HBOC-201 may reduce transfusion requirements in a non-cardiac surgery cohort. Although no significant difference in adverse events or mortality, a trend to higher incidence of both among the HBOC-201 group requires a much larger trial to be conducted before any conclusion regarding safety of such a novel therapy can be made.

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• Jan Van Hemelrijck, Lewis J Levien, Luc Veeckman, Arkadiy Pitman, Zafiris Zafirelis, and Thomas Standl.
• From the *Department of Anesthesiology, Universitaire Ziekenhuizen Katholieke Universiteit Leuven, Leuven, Belgium; †Department of Vascular Surgery, Milpark Hospital, Parktown, Johannesburg, South Africa; ‡Independent Biostatistics Consultant, Peabody, Massachusetts; §Independent Consultant, Needham, Massachusetts; ║Department of Anesthesiology, University Hospital, Eppendorf, Hamburg, Germany.
• Anesth. Analg.. 2014 Oct 1;119(4):766-76.

BackgroundWe present the results of a previously unpublished hemoglobin-based oxygen carrier (HBOC) study conducted in 1998-1999.MethodsIn a multicenter, randomized, single-blind, comparative study of HBOC-201 versus allogeneic red blood cell (RBC) transfusions, no-cardiac surgery patients received HBOC-201 to a maximum of 7 units (n = 83) or RBCs (n = 77). Patients could be switched to RBCs for safety or any other reason. The efficacy end points were elimination and/or reduction of allogeneic RBC transfusions for 28 days.ResultsThe proportion of patients in the HBOC-201 group that avoided RBC transfusion was 0.427 (95% confidence interval, 0.321-0.533). Subjects in the HBOC-201 group received on average 3.2 units of RBCs versus 4.4 units in the control arm (P = 0.004). Seventy-nine (95.2%) subjects in the HBOC-201 group and 72 (93.5%) in the RBC group experienced adverse events (AEs), judged to be associated with study treatment in 59 (71.1%) and 18 (23.4%) subjects, respectively. Thirty-day mortality, 5 (6.0%) vs 4 (5.2%) patients (P = 1.00), incidence of serious AEs, 24 (28.9%) vs 20 (26.0%) (P = 0.73), or time to intensive care unit (log-rank P = 0.15) or hospital discharge (log-rank P = 0.53) were similar for the HBOC-201 and RBC groups, respectively.ConclusionsUp to 7 units of HBOC-201 infused over the course of 6 days resulted in RBC transfusion avoidance in 43% of patients. There were no notable differences in mortality and serious AEs incidence. The use of HBOC-201 was associated with a notable excess of nonserious AEs.

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