Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Biopure Corporation |
---|---|
Information provided by: | Biopure Corporation |
ClinicalTrials.gov Identifier: | NCT00301483 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Crossover Assignment, Safety/Efficacy Study |
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) |
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 |
---|---|
1: Experimental
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.
|
2: Active Comparator
Standard Therapy
|
Other: Standard of Care
Standard Therapy
|
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:
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:
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Systolic Blood Pressure ≤ 100 mm Hg OR Sustained (≥ 10 minutes) Heart Rate ≥ 100
EXCLUSION CRITERIA:
Contact: Tiana Gorham | tgorham@biopure.com |
South Africa, Gauteng | |
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 |
Study Director: | A. Gerson Greenburg, MD, PhD | Biopure Corporation |
Principal Investigator: | Professor Ken D Boffard, MD | Wits University Medical School |
Responsible Party: | Biopure ( Biopurure Corporation ) |
Study ID Numbers: | HEM-0125 |
Study First Received: | March 10, 2006 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00301483 |
Health Authority: | South Africa: Medicines Control Council |
multiple trauma bleeding injuries gunshot wounds stab wounds |
penetrating injuries blunt trauma multiple wounds |
Multiple Trauma Wounds, Penetrating Wounds and Injuries Disorders of Environmental Origin |
HBOC 201 Wounds, Nonpenetrating Hemorrhage |
Therapeutic Uses Hematologic Agents Blood Substitutes Pharmacologic Actions |