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

This study is ongoing, but not recruiting participants.

Sponsored by:	Northfield Laboratories
Information provided by:	Northfield Laboratories
ClinicalTrials.gov Identifier:	NCT00076648

Purpose

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.

Condition	Intervention	Phase
Hemorrhagic Shock	Drug: Poly SFH-P Injection	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076648

Show 32 Study Locations

Sponsors and Collaborators

Northfield Laboratories

More Information

Study ID Numbers:	RTBSE-11-(N)
Study First Received:	January 28, 2004
Last Updated:	July 31, 2006
ClinicalTrials.gov Identifier:	NCT00076648
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Shock
Hemorrhage
Shock, Hemorrhagic

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009