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


CONCLUSIONS
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.
Levy
Jerrold H
JH
Emory University Hospital, Atlanta, GA, USA.
Goodnough
Lawrence T
LT
Greilich
Philip E
PE
Parr
Grant V S
GV
Stewart
Robert W
RW
Gratz
Irwin
I
Wahr
Joyce
J
Williams
John
J
Comunale
Mark E
ME
Doblar
Dennis
D
Silvay
George
G
Cohen
Marc
M
Jahr
Jonathan S
JS
Vlahakes
Gus J
GJ
D000368:Aged; D000740:Anemia / Q000628:therapy; D000818:Animals; D001802:Blood Substitutes / Q000627:therapeutic use*; D006348:Cardiac Surgical Procedures; D002417:Cattle; D004311:Double-Blind Method; D017707:Erythrocyte Transfusion; D005260:Female; D006454:Hemoglobins / Q000627:therapeutic use; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000628:therapy
D001802:Blood Substitutes; D006454:Hemoglobins; C096798:HBOC 201