HBOC-201 as an Alternative to Blood Transfusion: Efficacy and Safety Evaluation in a Multicenter Phase III Trial in Elective Orthopedic Surgery

• DOI: 10.1097/ta.0b013e318173a93f
• Publication Date: 2008-06-03T14:34:13Z
• Authors: Jonathan S. Jahr; Colin Mackenzie; L Bruce Pearce; Arkadiy Pitman; A Gerson Greenburg
• Keywords: Adult; Male; Blood Loss, Surgical; Middle Aged; Risk Assessment; Statistics, Nonparametric; 3. Good health; Hemoglobins; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Blood Substitutes; Elective Surgical Procedures; Evaluation Studies as Topic; Humans; Female; Orthopedic Procedures; Single-Blind Method; Safety; Erythrocyte Transfusion; Follow-Up Studies; Probability

Background: The ability of hemoglobin based oxygen carrier-201 (HBOC-201) to safely reduce and/or eliminate perioperative transfusion was studied in orthopedic surgery patients. Methods: A randomized, single-blind, packed red blood cell (PRBC)-controlled, parallel-group multicenter study conducted. Six hundred eighty-eight patients were randomized treatment with HBOC-201 (H, n = 350) or PRBC (R, 338) at the first decision. Primary endpoints avoidance and blinded assessment [Mann-Whitney estimator (MW)] safety noninferiority. Groups compared directly by paired/matching group analyses predicated on a prospectively defined dichotomy [treatment success (HH) vs. failure (HR)] H arm an equivalently [≤3 (R3−) >3 (R3+) units PRBC] R arm, need (moderate high) for additional carrying capacity. Results: total 59.4% avoided transfusion. Adverse events (8.47 5.88), serious adverse (SAEs) (0.35 0.25) per patient higher versus arms (p < 0.001 p 0.01) MW 0.561 (95 CI 0.528–0.594). HH R3- had identical (0.14) events/patient 0.519 (95% confidence limit 0.481–0.558), whereas incidence (0.63 0.47) HR R3+ 0.605 0.550–0.662). Age (>80 years), volume overload undertreatment contributed this imbalance. Conclusion: eliminated majority subjects. between (H R) analysis unfavorable likely related age, overload, isolated that could not be managed alone. However, <80 years old moderate clinical may avoid when treated up 10 HBOC-201.