HBOC-201 vasoactivity in a phase III clinical trial in orthopedic surgery subjects--extrapolation of potential risk for acute trauma trials

• Published in: The journal of trauma Vol. 66; no. 2; p. 365
• Main Authors: Freilich, Daniel, Pearce, L Bruce, Pitman, Arkadiy, Greenburg, Gerson, Berzins, Mara, Bebris, Lolita, Ahlers, Steven, McCarron, Richard
• Format: Journal Article
• Language: English
• Published: United States 01.02.2009
• Subjects: Adult; Aged; Blood Substitutes - adverse effects; Blood Substitutes - pharmacology; Clinical Trials as Topic; Erythrocyte Transfusion - adverse effects; Erythrocyte Transfusion - statistics & numerical data; Female; Hemoglobins - adverse effects; Hemoglobins - pharmacology; Humans; Linear Models; Male; Middle Aged; Orthopedics; Risk; Single-Blind Method

Vasoactivity has hampered progress of hemoglobin-based oxygen carriers (HBOCs) due to concern for adverse blood pressure responses and secondary complications. A recent formulation, highly polymerized HBOC-201 (Biopure, Cambridge, MA), has been found to be less vasoactive than prior less polymerized...