Study Design

Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study.

Official Title

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.

Protocol

Patients in hemorrhagic shock will begin to receive either saline (salt water, the standard of care) (control) or PolyHeme (investigational treatment) before arrival at the hospital, and continue for a 12 hour post injury period. In the hospital, patients in the control group will receive saline for hydration and blood if necessary. Unlimited doses of each are allowed. Patients in the treatment group will receive saline for hydration and PolyHeme to increase oxygen levels, up to a maximum dose of 6 units during the first 12 hours. Blood will be used thereafter.

Eligibility

Ages Eligible for Study: 18 Years and above
Genders Eligible for Study: Both

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).