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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Biopure Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Biopure Corporation
ClinicalTrials.gov Identifier:
NCT00301483
First received: March 10, 2006
Last updated: March 5, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Wounds and Injuries
Drug: Hemoglobin-based oxygen carrier-201 (HBOC 201)
Other: Standard of Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Single-Center, Study to Evaluate the Safety and Tolerability of Hemoglobin-Based Oxygen Carrier-201 (HBOC 201) in Trauma Subjects. (Phase II - Safety and Tolerability)

Resource links provided by NLM:


Further study details as provided by Biopure Corporation:

Primary Outcome Measures:
  • Safety/Tolerability of HBOC-201 for treatment of hypoperfusion in trauma by analysis of AEs/SAEs attributed to study drug [ Time Frame: Duration of the study (Randomization through 28-day follow-up) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Duration of the study (Randomization through 28-day follow-up) ] [ Designated as safety issue: No ]

Estimated Enrollment: 53
Study Start Date: July 2004
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
HBOC-201 followed by standard therapy
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.
Active Comparator: 2
Standard Therapy
Other: Standard of Care
Standard Therapy

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 potential for bleeding who require standard fluid therapy for treatment of hypoperfusion. The type and incidence of adverse events and serious adverse events attributed to the study drug will be analyzed.

Secondary variables in this safety and tolerability study, will be summarized with descriptive statistics and frequency tables. The purpose of this data collection is to assess efficacy variables and the feasibility of utilizing these parameters in future trauma studies that will assess parameters of morbidity and mortality and include, but are not limited to:

  • Time to improvement of serum (or plasma) lactate
  • Time to improvement in the Base Deficit
  • Time to maintained stability (BD<5) over 24 hours
  • Overall improvement in Base Deficit over 24 Hours
  • Stability of subjects at 24 hours
  • Time to meet treatment-stopping criteria
  • Volume to meet treatment-stopping criteria
  • Incidence of infectious complications (e.g., incidence of ventilator-associated pneumonia)
  • Length of time on ventilator
  • Incidence of multiple organ dysfunction (MOD)

Hemorrhage with subsequent hypoperfusion is a major cause of both immediate and delayed death in subjects who have sustained traumatic injuries. Effective therapies for hemorrhage to treat hypoperfusion that can be given immediately following injury are lacking. The following issues confound this problem further:

  • Hemorrhaging trauma victims often have an immediate need for therapy to ensure adequate delivery of oxygen to vital tissues;
  • Standard of care fluids such as Lactated Ringers Solution do not provide oxygen and blood can not be readily stored, transported or easily used in pre-hospital settings
  • In the absence of oxygen-carrying fluid, traditional approaches to sustain vital organ perfusion, such as administration of intravenous fluid therapy, may have detrimental effects if given prior to hemostasis in certain subjects, particularly those with penetrating truncal injuries.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301483

Contacts
Contact: Tiana Gorham tgorham@biopure.com

Locations
South Africa
Department of Surgery: Johannesburg Hospital Recruiting
Johannesburg, Gauteng, South Africa
Contact: Ronel Snyman    011 488 3943    research.jhb@mweb.co.za   
Principal Investigator: Professor Ken D Boffard, MD         
Sponsors and Collaborators
Biopure Corporation
Investigators
Study Director: A. Gerson Greenburg, MD, PhD Biopure Corporation
Principal Investigator: Professor Ken D Boffard, MD Wits University Medical School
  More Information

No publications provided

Responsible Party: Biopurure Corporation, Biopure
ClinicalTrials.gov Identifier: NCT00301483     History of Changes
Other Study ID Numbers: HEM-0125
Study First Received: March 10, 2006
Last Updated: March 5, 2008
Health Authority: South Africa: Medicines Control Council

Keywords provided by Biopure Corporation:
multiple trauma
bleeding injuries
gunshot wounds
stab wounds
penetrating injuries
blunt trauma
multiple wounds

Additional relevant MeSH terms:
Wounds and Injuries
HBOC 201
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014