Safety and Efficacy of PolyHeme(R) in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northfield Laboratories

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).