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

Abstract

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.

• Authors: Jerrold H Levy, Lawrence T Goodnough, Philip E Greilich, Grant V S Parr, Robert W Stewart, Irwin Gratz, Joyce Wahr, John Williams, Mark E Comunale, Dennis Doblar, George Silvay, Marc Cohen, Jonathan S Jahr, Gus J Vlahakes
• Journal: The Journal of thoracic and cardiovascular surgery (J Thorac Cardiovasc Surg) Vol. 124 Issue 1 Pg. 35-42 (Jul 2002) ISSN: 0022-5223 [Print] United States
• PMID: 12091806 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Blood Substitutes
• Hemoglobins
• HBOC 201

Topics

• Aged
• Anemia (therapy)
• Animals
• Blood Substitutes (therapeutic use)
• Cardiac Surgical Procedures
• Cattle
• Double-Blind Method
• Erythrocyte Transfusion
• Female
• Hemoglobins (therapeutic use)
• Humans
• Male
• Postoperative Complications (therapy)