title: 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.
  
  
  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.
authors.affiliation: Emory University Hospital, Atlanta, GA, USA.
authors.forename: Jerrold H
authors.initials: JH
authors.lastname: Levy
authors.forename: Lawrence T
authors.initials: LT
authors.lastname: Goodnough
authors.forename: Philip E
authors.initials: PE
authors.lastname: Greilich
authors.forename: Grant V S
authors.initials: GV
authors.lastname: Parr
authors.forename: Robert W
authors.initials: RW
authors.lastname: Stewart
authors.forename: Irwin
authors.initials: I
authors.lastname: Gratz
authors.forename: Joyce
authors.initials: J
authors.lastname: Wahr
authors.forename: John
authors.initials: J
authors.lastname: Williams
authors.forename: Mark E
authors.initials: ME
authors.lastname: Comunale
authors.forename: Dennis
authors.initials: D
authors.lastname: Doblar
authors.forename: George
authors.initials: G
authors.lastname: Silvay
authors.forename: Marc
authors.initials: M
authors.lastname: Cohen
authors.forename: Jonathan S
authors.initials: JS
authors.lastname: Jahr
authors.forename: Gus J
authors.initials: GJ
authors.lastname: Vlahakes
mesh_terms: 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
chemical_list: D001802:Blood Substitutes; D006454:Hemoglobins; C096798:HBOC 201