Wounds and Injuries Clinical Trial
Official title:
A Single-Center, Study to Evaluate the Safety and Tolerability of Hemoglobin-Based Oxygen Carrier-201 (HBOC 201) in Trauma Subjects. (Phase II - Safety and Tolerability)
The main purpose of this study is to determine if HBOC-201 is safe and tolerable to trauma subjects, when given to treat the inadequate supply of blood and nutrients to tissues and organs.
Status | Recruiting |
Enrollment | 53 |
Est. completion date | December 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
South Africa | Department of Surgery: Johannesburg Hospital | Johannesburg | Gauteng |
Lead Sponsor | Collaborator |
---|---|
Biopure Corporation |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety/Tolerability of HBOC-201 for treatment of hypoperfusion in trauma by analysis of AEs/SAEs attributed to study drug | Duration of the study (Randomization through 28-day follow-up) | Yes | |
Secondary | Efficacy/feasibility of the following measurements in trauma studies (list is not all inclusive): Time to serum lactate improvement, Base deficit (BD) improvement, BD > 5 over 24 hrs, 24 hr stability, Infection, Vent time | Duration of the study (Randomization through 28-day follow-up) | No |
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