Diaspirin Crosslinked Hemoglobin (DCLHbTM): Bioanalytical Studies in Swine

These studies were a part of preclinical safety and efficacy studies of DCLHb. Their purpose was to analyze the characteristics of DCLHb during circulation, and the distribution of iron following the administration of DCLHb to swine. Swine were dosed (2 g/kg) with 10 g/dL DCLHb, infused intravenously at a rate of 1 mL/kg/min. Blood samples were collected up to 48 hours post-infusion for analysis. Tissue samples were obtained for iron determination. The data collected showed that the concentration of DCLHb in the plasma gradually decreased, while the concentration of methemoglobin remained low and essentially constant. The oxygen binding characteristics and stability of the crosslink were preserved following infusion, indicating that the DCLHb continued to function as an effective oxygen carrier. Iron concentrations in the liver and kidneys increased as expected, but plasma levels of iron did not saturate the iron binding capacity of transferrin, inferring a controlled process for the release of iron.