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

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ClinicalTrials.gov Identifier: NCT00328133
Recruitment Status : Completed
First Posted : May 19, 2006
Last Update Posted : May 10, 2012
Sponsor:
Collaborators:
Western Trauma Association
Novo Nordisk A/S
American Association for the Surgery of Trauma
Information provided by (Responsible Party):
University of California, San Francisco

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
Traumatic Hemorrhage Hemorrhagic Shock

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 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 : June 2006
Primary Completion Date : June 2010
Study Completion Date : June 2011

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U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Retrospective and prospective observational case review study on traumatically injured adult patients.
Criteria

Inclusion Criteria:

Coagulopathy treated with rFVIIa

Exclusion Criteria:


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): NCT00328133


Locations
United States, California
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

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00328133     History of Changes
Other Study ID Numbers: H6693-27309-01
First Posted: May 19, 2006    Key Record Dates
Last Update Posted: May 10, 2012
Last Verified: May 2012

Keywords provided by University of California, San Francisco:
recombinant Factor VIIa
traumatic hemorrhage
hemorrhagic shock
coagulopathy

Additional relevant MeSH terms:
Hemorrhage
Shock, Hemorrhagic
Pathologic Processes
Shock