A Single Site Safety and Tolerability Study of HBOC-201 in Trauma Subjects
Wounds and Injuries
About this trial
This is an interventional treatment trial for Wounds and Injuries focused on measuring multiple trauma, bleeding injuries, gunshot wounds, stab wounds, penetrating injuries, blunt trauma, multiple wounds
Eligibility Criteria
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
Sites / Locations
- Department of Surgery: Johannesburg HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2
HBOC-201 followed by standard therapy
Standard Therapy