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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by:
Northfield Laboratories

Study Description
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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

Study Design
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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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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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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
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
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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


Locations
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Sponsors and Collaborators
Northfield Laboratories
More Information
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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
Shock, Hemorrhagic
Wounds and Injuries
Pathologic Processes
Hemorrhage