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

Completed

• Conditions: Traumatic Hemorrhage; Hemorrhagic Shock

• Registration Number: NCT00328133
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2006-05-17
• Study First Submitted QC: 2006-05-17
• Study First Posted: 2006-05-19
• Study Start: 2006-06
• Primary Completion: 2010-06
• Study Completion: 2011-06
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-09
• Last Update Posted: 2012-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

Coagulopathy treated with rFVIIa

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of California San Francisco, San Francisco General Hospital; 🇺🇸 San Francisco, California, United States