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

PHASE2UnknownINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

July 31, 2004

Primary Completion Date

September 30, 2008

Study Completion Date

December 31, 2008

Conditions
Wounds and Injuries
Interventions
DRUG

Hemoglobin-based oxygen carrier-201 (HBOC 201)

HBOC-201 is an investigational solution of sterile, ultrapurified, glutaraldehyde polymerized, modified bovine hemoglobin (Hb) in a balanced electrolyte solution. HBOC-201 has an Hb concentration of 12-14g/dL. HBOC-201 is an isosmotic solution that is stable for at least 36 months at 2-30ºC. It requires no reconstitution and can be administered directly into a peripheral or central vein. Blood typing is not required because all other cellular components, including the RBC membranes that carry the blood group antigens, have been removed.

OTHER

Standard of Care

Standard Therapy

Trial Locations (1)

Unknown

RECRUITING

Department of Surgery: Johannesburg Hospital, Johannesburg

Sponsors
All Listed Sponsors
lead

Biopure Corporation

INDUSTRY

NCT00301483 - A Single Site Safety and Tolerability Study of HBOC-201 in Trauma Subjects | Biotech Hunter | Biotech Hunter