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The Use of rFVIIa in Trauma Patients: A Multi-Center Case Registry

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT00328133
Collaborator
Western Trauma Association (Other), Novo Nordisk A/S (Industry), American Association for the Surgery of Trauma (Other)
380
Enrollment
1
Location
60
Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Trauma surgeons throughout the US have begun using recombinant activated factor VII (rFVIIa) to control severe hemorrhage following injury when traditional measures have failed. Despite promising results from several small studies, there remain several unanswered questions regarding the use of this relatively expensive product in injured patients including:

  • The timing of administration

  • Selection of appropriate patients who are most likely to benefit

  • The effective dose in injured patients

  • The potential need for repeated dosing

  • The need for administration of platelets and correction of acidosis prior to administering the first dose

  • The risks associated with the use of rFVIIa including venous and/or arterial thrombosis

  • The potential for rFVIIa to cause or aggravate post-injury organ failure and/or infectious complications

  • An analysis of cost versus benefit The purpose of this study is to collect a large sample of patients from multiple institutions in order to address the issues listed above. To this end, the Western Trauma Association Foundation is sponsoring a multi-center case registry for patients receiving rFVIIa for treatment of uncontrolled hemorrhage.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a prospective, multi-center case registry that seeks to combine the collective experience with the use of rFVIIa at UCSF/SFGH with other trauma centers. The study is being conducted under the auspices of the Western Trauma Association and the American Association of the Surgery of Trauma. Both organizations have a long history of successfully completing multi-center studies. The outcomes to be used in this study are: 1) survival, 2) amount of blood products infused before and after rFVIIa, 3) coagulation factors (PTT, INR) before and after, and 4) the surgeon's assessment of hemostasis. Data will also be analyzed to determine the cost effectiveness of rFVIIa when compared with other methods of treating severe hemorrhage, primarily administration of blood products. Finally, the incidence of complications and thrombotic events after drug administration will be evaluated.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    380 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Use of rFVIIa in Trauma Patients: A WTA/AAST Multi-Center Case Registry
    Study Start Date :
    Jun 1, 2006
    Actual Primary Completion Date :
    Jun 1, 2010
    Actual Study Completion Date :
    Jun 1, 2011

    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:

      Coagulopathy treated with rFVIIa

      Exclusion Criteria:

      none

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University of California San Francisco, San Francisco General Hospital San Francisco California United States 94110

      Sponsors and Collaborators

      • University of California, San Francisco
      • Western Trauma Association
      • Novo Nordisk A/S
      • American Association for the Surgery of Trauma

      Investigators

      • Principal Investigator: Margaret Knudson, MD, University of California, San Francisco

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      University of California, San Francisco
      ClinicalTrials.gov Identifier:
      NCT00328133
      Other Study ID Numbers:
      • H6693-27309-01
      First Posted:
      May 19, 2006
      Last Update Posted:
      May 10, 2012
      Last Verified:
      May 1, 2012
      Keywords provided by University of California, San Francisco
      recombinant Factor VIIa
      traumatic hemorrhage
      hemorrhagic shock
      coagulopathy
      Additional relevant MeSH terms:
      Hemorrhage
      Shock, Hemorrhagic

      Study Results

      No Results Posted as of May 10, 2012