Hemorrhagic Shock Clinical Trial
Official title:
The Use of rFVIIa in Trauma Patients: A WTA/AAST Multi-Center Case Registry
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.
Status | Completed |
Enrollment | 380 |
Est. completion date | June 2011 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Coagulopathy treated with rFVIIa Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | University of California San Francisco, San Francisco General Hospital | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | American Association for the Surgery of Trauma, Novo Nordisk A/S, Western Trauma Association |
United States,
Knudson MM, Cohen MJ, Reidy R, Jaeger S, Bacchetti P, Jin C, Wade CE, Holcomb JB. Trauma, transfusions, and use of recombinant factor VIIa: A multicenter case registry report of 380 patients from the Western Trauma Association. J Am Coll Surg. 2011 Jan;21 — View Citation
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