title: A safety and efficacy evaluation of hemoglobin-based oxygen carrier HBOC-201 in a randomized, multicenter red blood cell controlled trial in noncardiac surgery patients.
abstract: BACKGROUND
  We present the results of a previously unpublished hemoglobin-based oxygen carrier (HBOC) study conducted in 1998-1999.
  
  
  METHODS
  In a multicenter, randomized, single-blind, comparative study of HBOC-201 versus allogeneic red blood cell (RBC) transfusions, no-cardiac surgery patients received HBOC-201 to a maximum of 7 units (n = 83) or RBCs (n = 77). Patients could be switched to RBCs for safety or any other reason. The efficacy end points were elimination and/or reduction of allogeneic RBC transfusions for 28 days.
  
  
  RESULTS
  The proportion of patients in the HBOC-201 group that avoided RBC transfusion was 0.427 (95% confidence interval, 0.321-0.533). Subjects in the HBOC-201 group received on average 3.2 units of RBCs versus 4.4 units in the control arm (P = 0.004). Seventy-nine (95.2%) subjects in the HBOC-201 group and 72 (93.5%) in the RBC group experienced adverse events (AEs), judged to be associated with study treatment in 59 (71.1%) and 18 (23.4%) subjects, respectively. Thirty-day mortality, 5 (6.0%) vs 4 (5.2%) patients (P = 1.00), incidence of serious AEs, 24 (28.9%) vs 20 (26.0%) (P = 0.73), or time to intensive care unit (log-rank P = 0.15) or hospital discharge (log-rank P = 0.53) were similar for the HBOC-201 and RBC groups, respectively.
  
  
  CONCLUSIONS
  Up to 7 units of HBOC-201 infused over the course of 6 days resulted in RBC transfusion avoidance in 43% of patients. There were no notable differences in mortality and serious AEs incidence. The use of HBOC-201 was associated with a notable excess of nonserious AEs.
authors: From the Department of Anesthesiology, Universitaire Ziekenhuizen Katholieke Universiteit Leuven, Leuven, Belgium; Department of Vascular Surgery, Milpark Hospital, Parktown, Johannesburg, South Africa; Independent Biostatistics Consultant, Peabody, Massachusetts; Independent Consultant, Needham, Massachusetts; Department of Anesthesiology, University Hospital, Eppendorf, Hamburg, Germany.
authors: Jan
authors: J
authors: Van Hemelrijck
authors: Lewis J
authors: LJ
authors: Levien
authors: Luc
authors: L
authors: Veeckman
authors: Arkadiy
authors: A
authors: Pitman
authors: Zafiris
authors: Z
authors: Zafirelis
authors: Thomas
authors: T
authors: Standl
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001802:Blood Substitutes / Q000008:administration & dosage* / Q000009:adverse effects*; D004341:Drug Evaluation / Q000379:methods; D017707:Erythrocyte Transfusion / Q000009:adverse effects* / Q000379:methods; D005260:Female; D005334:Fever / Q000139:chemically induced / Q000175:diagnosis; D005500:Follow-Up Studies; D006454:Hemoglobins / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D006973:Hypertension / Q000139:chemically induced / Q000175:diagnosis; D008297:Male; D008875:Middle Aged; D019990:Perioperative Care / Q000009:adverse effects / Q000379:methods*; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001802:Blood Substitutes; D006454:Hemoglobins; C096798:HBOC 201