Trial | NCT00076648  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    hemoglobin ...

  • Study Participants

    None
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.
Study Started
Jan 28
2004
Last Update
Aug 02
2006
Estimate

Drug Poly SFH-P Injection

Criteria 

Inclusion Criteria:

Adult patients following trauma who have sustained blood loss and are in shock

Exclusion Criteria:

Patients who have sustained unsurvivable injuries
Patients who have severe head injury
Pregnant females
Patients found in cardiac arrest
Patients who object to participation (e.g., religious grounds, wearing exclusion bracelet).
No Results Posted