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NCT00328133 · ClinicalTrials.gov registry record
The Use of rFVIIa in Trauma Patients: A Multi-Center Case Registry
A clinical trial, sponsored by University of California, San Francisco.
- Completed
- Registry status
- 380
- Enrollment target
NCT00328133 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 380 participants.
The verdict
NCT00328133 has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- 380 participants
- Enrollment target
Study 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2006-06 |
| Est. Completion | 2011-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00328133
The ClinicalTrials.gov registry entry for NCT00328133 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 380 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00328133 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00328133 about?
NCT00328133 is a clinical study titled "The Use of rFVIIa in Trauma Patients: A 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 ...
What is the current status of trial NCT00328133?
This trial is currently completed. The enrollment target is 380 participants. The study started on 2006-06. Estimated completion is 2011-06.
Who is sponsoring clinical trial NCT00328133?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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