Key Adverse Events in Recent HBOC Phase III Clinical Trials and Their Causal Relationship to Test HBOC’s

Abstract

Synopsis: Hemoglobin based oxygen carriers (HBOC) are used for management of acute surgical and medical anemia. In this chapter, the clinical application, dosing, administration, side effects and toxicities of three HBOC that have undergone recent Phase III clinical trials are discussed. Side effects include gastrointestinal (nausea, vomiting, diarrhea, abdominal pain and bloating), skin rashes, jaundice without elevated bilirubin, fever, and plasma hemoglobin interference with laboratory assays, and methemoglobinemia. Toxicities of these three HBOC include elevated blood pressure, hemostatic effects, myocardial infarction and in the elderly, stroke. HBOC because of side effects, are not ideal resuscitation fluids from acute anemia, but have advantages when blood is unavailable or refused. HBOC could be useful in the pre-hospital environment, military conflicts, disasters, and in the developing world, and in other situations where blood is not readily accessible. HBOC management of acute anemia is not without risk, but should be used when the benefits outweigh such risks, as HBOC toxicities are transient, readily reversible, and less than 1 % result in fatalities.