Status:
UNKNOWN
A Single Site Safety and Tolerability Study of HBOC-201 in Trauma Subjects
Lead Sponsor:
Biopure Corporation
Conditions:
Wounds and Injuries
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
This Phase II study will be a single-center, randomized, single-blind, parallel-group, standard therapy-controlled, variable dose study of HBOC 201 administered to trauma subjects with bleeding or pot...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00301483
Start Date
July 1 2004
End Date
December 1 2008
Last Update
March 6 2008
Active Locations (1)
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1
Department of Surgery: Johannesburg Hospital
Johannesburg, Gauteng, South Africa