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

Sponsor
Northfield Laboratories (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00076648
Collaborator
(none)
32
Locations

Study Details

Study Description

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
  • Drug: Poly SFH-P Injection
 Phase 3

Study Design

Study Type:
Interventional
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scripps Mercy San Diego California United States 92103
    2 UC San Diego Medical Center San Diego California United States 92103
    3 Denver Health Medical Center Denver Colorado United States 80204
    4 Christiana Hospital Newark Delaware United States 19718
    5 Medical Center of Central Georgia Macon Georgia United States 31201
    6 Loyola University Medical Center Maywood Illinois United States 60153
    7 Methodist Hospital of Indiana Indianapolis Indiana United States 46202
    8 Wishard Memorial Hospital Indianapolis Indiana United States 46202
    9 University of Kansas Medical Center Kansas City Kansas United States 66160
    10 University of Kentucky Medical Center Lexington Kentucky United States 40536
    11 Detroit Receiving Hospital Detroit Michigan United States 48201
    12 Sinai Grace Hospital Detroit Michigan United States 48201
    13 The Mayo Clinic Rochester Minnesota United States 55905
    14 Albany Medical Center Albany New York United States 12208
    15 Duke University Medical Center Durham North Carolina United States 27710
    16 University of Cincinnati Medical Center Cincinnati Ohio United States 45267-0769
    17 MetroHealth Medical Center Cleveland Ohio United States 44109
    18 Miami Valley Hospital Dayton Ohio United States 45409
    19 Lehigh Valley Hospital Allentown Pennsylvania United States 18103
    20 St. Luke's Regional Resource Trauma Center Bethlehem Pennsylvania United States 18015
    21 Penn State Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    22 Johnson City Medical Center Johnson City Tennessee United States 37604
    23 University of Tennessee-Memphis Memphis Tennessee United States 38163
    24 Brooke Army Medical Center Fort Sam, Houston Texas United States 78234-6315
    25 Memorial-Hermann Hospital Houston Texas United States 77030
    26 University of Texas Health Science Center San Antonio Texas United States 78284
    27 University of Utah Health Sciences Center Salt Lake City Utah United States 84132
    28 LDS Hospital Salt Lake City Utah United States 84143
    29 Inova Fairfax Hospital Falls Church Virginia United States 22066
    30 Sentara Norfolk Hospital Norfolk Virginia United States 23507
    31 Virginia Commonwealth University Medical Center Richmond Virginia United States 23298-0454
    32 West Virginia University/Jon Michael Moore Trauma Center Morgantown West Virginia United States 26506

    Sponsors and Collaborators

    • Northfield Laboratories

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00076648
    Other Study ID Numbers:
    • RTBSE-11-(N)
    First Posted:
    Jan 30, 2004
    Last Update Posted:
    Aug 2, 2006
    Last Verified:
    Jul 1, 2006
    Additional relevant MeSH terms:
    Shock
    Shock, Hemorrhagic
    Wounds and Injuries

    Study Results

    No Results Posted as of Aug 2, 2006