MONDAY, June 16 (HealthDay News) -- In the largest randomized controlled study to date of hemoglobin-based oxygen carrier (HBOC) use in elective orthopedic surgical patients, the majority of patients treated with HBOC-201 were able to safely avoid red blood cell transfusions, researchers report in the June issue of the Journal of Trauma: Injury, Infection, and Critical Care.
Jonathan S. Jahr, M.D., of the David Geffen School of Medicine at the University of California Los Angeles, and colleagues conducted a single-blind, controlled multicenter study of 688 elective orthopedic surgery patients, who were randomly assigned to receive either HBOC-201 or packed red-blood cell transfusions, based on transfusion need. Some of the patients who received HBOC-201 subsequently needed additional treatment with red-blood cell transfusions. The major endpoints were elimination of the need for blood transfusions in at least 35 percent of patients, and safety.
The researchers found that 59.4 percent of patients in the HBOC-201 arm of the study did not need a blood transfusion. More patients who took HBOC-201 than red-blood cell transfusions, however, had adverse events (8.47 percent versus 5.88 percent, respectively) or serious adverse events (0.35 percent versus 0.25 percent, respectively). The authors observe that safety problems were isolated to those who could not be treated only with HBOC-201.
"HBOC-201 eliminated transfusion in the majority of subjects," the authors write. Despite unfavorable safety data for a subset of patients treated with HBOC-201 who also needed transfusions, "patients under 80 years old with moderate clinical need may safely avoid transfusion when treated with up to 10 units of HBOC-201," Jahr and colleagues conclude.
Abstract
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