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

• Published in: Anesthesia & Analgesia Vol. 119; no. 4; pp. 766 - 776
• Main Authors: Van Hemelrijck, Jan, Levien, Lewis J., Veeckman, Luc, Pitman, Arkadiy, Zafirelis, Zafiris, Standl, Thomas
• Format: Journal Article
• Language: English
• Published: United States Ovid Technologies (Wolters Kluwer Health) 01.10.2014; International Anesthesia Research Society
• Subjects: Adult; Aged; Aged, 80 and over; Blood Substitutes; Blood Substitutes - administration & dosage; Blood Substitutes - adverse effects; Drug Evaluation; Drug Evaluation - methods; Erythrocyte Transfusion; Erythrocyte Transfusion - adverse effects; Erythrocyte Transfusion - methods; Female; Fever; Fever - chemically induced; Fever - diagnosis; Follow-Up Studies; Hemoglobins; Hemoglobins - administration & dosage; Hemoglobins - adverse effects; Humans; Hypertension; Hypertension - chemically induced; Hypertension - diagnosis; Male; Middle Aged; Perioperative Care; Perioperative Care - adverse effects; Perioperative Care - methods; Single-Blind Method; Treatment Outcome; Young Adult
• ISSN: 0003-2999; 1526-7598; 1526-7598
• DOI: 10.1213/ANE.0000000000000305

BACKGROUND:We present the results of a previously unpublished hemoglobin-based oxygen carrier (HBOC) study conducted in 1998–1999.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.