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

NCT00328133 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 380

Last updated 2012-05-10

No results posted yet for this 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.

Conditions

  • Traumatic Hemorrhage
  • Hemorrhagic Shock

Sponsors & Collaborators

Principal Investigators

  • Margaret Knudson, MD · University of California, San Francisco

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2010-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00328133 on ClinicalTrials.gov