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

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ClinicalTrials.gov Identifier: NCT00076648
Recruitment Status : Unknown
Verified July 2006 by Northfield Laboratories.
Recruitment status was:  Active, not recruiting
First Posted : January 30, 2004
Last Update Posted : August 2, 2006
Information provided by:
Northfield Laboratories

Brief Summary:
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 or disease Intervention/treatment Phase
Hemorrhagic Shock Drug: Poly SFH-P Injection Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076648

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Sponsors and Collaborators
Northfield Laboratories
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00076648    
Other Study ID Numbers: RTBSE-11-(N)
First Posted: January 30, 2004    Key Record Dates
Last Update Posted: August 2, 2006
Last Verified: July 2006
Additional relevant MeSH terms:
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Shock, Hemorrhagic
Wounds and Injuries
Pathologic Processes