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

Hemorrhagic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328133
• Other study ID #: H6693-27309-01
• Status: Completed
• Phase: N/A
• First received: May 17, 2006
• Last updated: May 9, 2012
• Start date: June 2006
• Est. completion date: June 2011

Study information

• Verified date: May 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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:

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hemorrhage
• Hemorrhagic Shock
• Shock, Hemorrhagic
• Traumatic Hemorrhage

Locations

Country	Name	City	State
United States	University of California San Francisco, San Francisco General Hospital	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	American Association for the Surgery of Trauma, Novo Nordisk A/S, Western Trauma Association

Country where clinical trial is conducted

United States, 

References & Publications (1)

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