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

NCT00301483 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2008-03-06

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Biopure Corporation

    lead INDUSTRY

Principal Investigators

  • A. Gerson Greenburg, MD, PhD · Biopure Corporation

  • Professor Ken D Boffard, MD · Wits University Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2008-09-30
Completion
2008-12-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00301483 on ClinicalTrials.gov