Trials / Unknown
UnknownNCT00076648
Safety and Efficacy of PolyHeme(R) in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting
A Phase III, Randomized, Controlled, Open-Label, Multicenter, Parallel Group Study Using Provisions for Exception From Informed Consent Requirements Designed to Evaluate the Safety and Efficacy of Poly SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme(R)] When Used to Treat Patients in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Prehospital Setting
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Northfield Laboratories · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to assess the survival benefit of administering PolyHeme to severely injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where blood is not available, and continuing throughout a 12-hour postinjury hospital setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Poly SFH-P Injection |
Timeline
- First posted
- 2004-01-30
- Last updated
- 2006-08-02
Locations
32 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00076648. Inclusion in this directory is not an endorsement.