Trials / Unknown
UnknownNCT00301535
A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery
Enhancement of Tissue Preservation During Cardiopulmonary Bypass With HBOC-201 (Registry Study)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Biopure Corporation · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if Hemopure® will enhance tissue preservation during Cardiopulmonary Bypass surgery.
Detailed description
The primary objective is to determine the safety and feasibility of administering Hemopure® (HBOC-201) to reduce myocardial necrosis, as measured by CK-MB enzyme elevation, and enhance tissue preservation during cardiopulmonary bypass.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HBOC-201 (hemoglobin glutamer-250 bovine) | HBOC-201 is an investigational solution of purified, glutaraldehyde-polymerized bovine hemoglobin with a concentration of hemoglobin of 13 ± 1 g/dL |
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2008-07-01
- Completion
- 2008-09-01
- First posted
- 2006-03-13
- Last updated
- 2008-05-16
Locations
3 sites across 3 countries: Greece, South Africa, United Kingdom
Source: ClinicalTrials.gov record NCT00301535. Inclusion in this directory is not an endorsement.