A Single Site Safety and Tolerability Study of HBOC-201 in Trauma Subjects

INCLUSION CRITERIA: * Male or Female (females not of childbearing potential or negative pregnancy test prior to enrollment) * Age ≥ 18 years and ≤ 65 years of age * Trauma with bleeding or a potential for bleeding arriving at initial treatment facility directly from scene of injury * Subject should be enrolled within four (4) hours of injury * Base Deficit (BD) greater than 5.0 and one of the following: Systolic Blood Pressure ≤ 100 mm Hg OR Sustained (≥ 10 minutes) Heart Rate ≥ 100 * No localized signs of traumatic brain injury and a Glasgow Coma Score of ≥9 with the exception of drug-induced lowered GCS. * Informed consent, or independent physician authorization obtained EXCLUSION CRITERIA: * Known or suspected Traumatic Brain Injury * Non-survivable injury (Falcone Criteria) * Traumatic arrest * Known prior cardiac arrest (i.e., preceding trauma episode) * Known or suspected pregnancy * Known allergy to bovine products * Prior treatment with blood (subsequent to current trauma) * Informed consent or independent physician authorization unable to be obtained * Unable to meet protocol or follow-up criteria