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

NCT00301483 | Unknown Phase 2 DMC

• 1 other identifier: HEM-0125
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries

Keywords

multiple trauma; bleeding injuries; gunshot wounds; stab wounds; penetrating injuries; blunt trauma; multiple wounds

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• 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)

Study Arms (2)

1

EXPERIMENTAL

HBOC-201 followed by standard therapy

Drug: Hemoglobin-based oxygen carrier-201 (HBOC 201)

2

ACTIVE COMPARATOR

Standard Therapy

Other: Standard of Care

Interventions

Hemoglobin-based oxygen carrier-201 (HBOC 201) DRUG

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.

1

Standard of Care OTHER

Standard Therapy

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biopure Corporation: lead

Study Sites (1)

Department of Surgery: Johannesburg Hospital

Johannesburg, Gauteng, South Africa

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Multiple Trauma; Wounds, Gunshot; Wounds, Stab; Wounds, Nonpenetrating

Interventions

HBOC 201; Standard of Care

Condition Hierarchy (Ancestors)

Wounds, Penetrating

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• A. Gerson Greenburg, MD, PhD

  Biopure Corporation

  STUDY DIRECTOR

• Professor Ken D Boffard, MD

  Wits University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiana Gorham

CONTACT

tgorham@biopure.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 10, 2006
• First Posted: March 13, 2006
• Study Start: July 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 6, 2008

Record last verified: 2008-02

Locations

ZA (1)