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

Northfield Laboratories

Status and phase: Unknown; Phase 3

Conditions: Hemorrhagic Shock

Treatments: Drug: Poly SFH-P Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00076648

RTBSE-11-(N)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)