Blood Component Requirements and Erythrocyte Transfusion and Mortality Related to Hemoglobin Deficit in Phase III Trial of Hemoglobin-Based Oxygen Carrier: HBOC-201

Hemoglobin-based oxygen carriers (HBOCs) may cause coagulopathy, changes in total hemoglobin (THb), and affect mortality. Low total hemoglobin concentrations [THb] during hemorrhage may worsen outcomes.The database of the Hemopure HEM-0115 phase III trial was queried to determine the use of platelets, plasma, or cryoprecipitate and compare transfusion requirements and coagulation studies between patients randomized to erythrocyte transfusion or HBOC-201 infusion. Modeling of hemoglobin (Hb) changes produced by HBOC-201, erythrocyte, and blood product administration were related to [THb], coagulopathy, and mortality.Hemopure HEM-0115 phase III trial database.Retrospective and Novel Hemoglobin Deficit Formulas Tested Against Existing Database.The HBOC-201 database (n = 688) demonstrated less than 6% of subjects in both groups were administered non-Hb containing blood products (fresh frozen plasma, platelets, or cryoprecipitate) and low rates of coagulopathies in both erythrocyte and HBOC-201 arms. There were no differences in mortality in elective orthopedic patients administered up to 10 bags HBOC-201 (equivalent to 3 units erythrocytes). Low total [Hb] and lack of adequate oxygen carrying capacity was found to be an independent predictor of morbidity/mortality.The elective use of HBOC-201 for orthopedics versus erythrocytes demonstrated low incidence of blood product requirements in both cohorts and no differences in mortality up to the HBOC-201 equivalent of 3 units erythrocytes. High total Hb may be important to maintain in acute hemorrhage and [Hb] deficit, whereas later in recovery might not be as crucial. Future trauma trials may benefit from the use of HBOC-201 containing 13 g/dL in prehospital management, when erythrocytes are commonly not available.