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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.

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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

FieldValue
Enrollment Target 380 participants
Start Date 2006-06
Est. Completion 2011-06

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.