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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Northfield Laboratories.
Recruitment status was  Active, not recruiting
Information provided by:
Northfield Laboratories Identifier:
First received: January 28, 2004
Last updated: July 31, 2006
Last verified: July 2006
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Northfield Laboratories:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00076648

  Show 32 Study Locations
Sponsors and Collaborators
Northfield Laboratories
  More Information

No publications provided by Northfield Laboratories

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00076648     History of Changes
Other Study ID Numbers: RTBSE-11-(N) 
Study First Received: January 28, 2004
Last Updated: July 31, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Shock, Hemorrhagic
Wounds and Injuries
Pathologic Processes processed this record on February 04, 2016