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

• Status: Unknown status
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biopure Corporation
• Treatments: HBOC 201

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