This trial is active, not recruiting.

Condition hemorrhagic shock
Treatment poly sfh-p injection
Phase phase 3
Sponsor Northfield Laboratories
Trial identifier NCT00076648, RTBSE-11-(N)


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2006.
Information provided to ClinicalTrials.gov by Northfield Laboratories.