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J Thorac Cardiovasc Surg 2002;124:35-42
© 2002 The American Association for Thoracic Surgery

Cardiopulmonary Support and Physiology (CSP)

Polymerized bovine hemoglobin solution as a replacement for allogeneic red blood cell transfusion after cardiac surgery: Results of a randomized, double-blind trial

From Emory University Hospital, Atlanta, Ga^a; Washington University School of Medicine, St Louis, Mo^b; Dallas Veterans Administration Medical Center, Dallas, Tex^c; Morristown Memorial Hospital, Morristown, NJ^d; University Hospitals of Cleveland, Cleveland, Ohio^e; Cooper Hospital/University Medical Center, Camden, NJ^f; University of Michigan Medical Center, Ann Arbor, Mich^g; UCLA School of Medicine, Los Angeles, Calif^h; Beth Israel-Deaconess Medical Center, Boston, Massⁱ; University of Alabama at Birmingham, Birmingham, Ala^j; The Mount Sinai Medical Center, New York, NY^k; Hahnemann University Hospital, Philadelphia, Pa^l; University of California, Davis Medical Center, Sacramento, Calif^m; and Massachusetts General Hospital, Boston, Mass.ⁿ

This clinical trial was sponsored by the Biopure Corporation, which provided the polymerized hemoglobin solution used in this clinical trial and provided financial support for the clinical study nurses and additional laboratory analyses required by the clinical protocol.

Received for publication Feb 12, 2001. Revisions requested May 17, 2001; revisions received Oct 30, 2001. Accepted for publication Nov 7, 2001. Address for reprints: Gus J. Vlahakes, MD, Division of Cardiac Surgery, Massachusetts General Hospital, 55 Fruit St-BUL119, Boston, MA 02114-2696 (E-mail: vlahakes.gus{at}MGH.Harvard.edu).

Background: Blood loss leading to reduced oxygen-carrying capacity is usually treated with red blood cell transfusions. This study examined the hypothesis that a hemoglobin-based oxygen-carrying solution can serve as an initial alternative to red blood cell transfusion.
Methods: In a randomized, double-blind efficacy trial of HBOC-201, a total of 98 patients undergoing cardiac surgery and requiring transfusion were randomly assigned to receive either red blood cell units or HBOC-201 (Hemopure; Biopure Corporation, Cambridge, Mass) for the first three postoperative transfusions. Patients were monitored before and after transfusion, at discharge, and at 3 to 4 weeks after the operation for subsequent red blood cell use, hemodynamics, and clinical laboratory parameters.
Results: The use of HBOC-201 eliminated the need for red blood cell transfusions in 34% of cases (95% confidence interval 21%-49%). Patients in the HBOC group received a mean of 1.72 subsequent units of red blood cells; those who received red blood cells only received a mean of 2.19 subsequent units (P = .05). Hematocrit values were transiently lower in the HBOC group but were similar in the two groups at discharge and follow-up. Oxygen extraction was greater in the HBOC group (P = .05). Mean increases in blood pressure were greater in the HBOC group, but not significantly so.
Conclusion: HBOC-201 may be an initial alternative to red blood cell transfusions for patients with moderate anemia after cardiac surgery. In a third of cases, HBOC-201 eliminated the need for red blood cell transfusion, although substantial doses were needed to produce this modest degree of blood conservation.

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