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

Sponsors and Collaborators:	University of California, San Francisco Western Trauma Association Novo Nordisk American Association for the Surgery of Trauma
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00328133

Purpose

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.

Condition
Uncontrolled Traumatic Hemorrhage Hemorrhagic Shock

Study Type:	Observational
Study Design:	Natural History, Cross-Sectional, Case Control, Retrospective/Prospective Study
Official Title:	The Use of rFVIIa in Trauma Patients: A WTA/AAST Multi-Center Case Registry

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Estimated Enrollment:	1000
Study Start Date:	June 2006

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Coagulopathy treated with rFVIIa

Exclusion Criteria:

none

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328133

Contacts

Contact: Margaret M Knudson, MD

415-206-4623

pknudson@sfghsurg.ucsf.edu

Locations

United States, California
University of California San Francisco, San Francisco General Hospital
San Francisco, California, United States, 94110

Sponsors and Collaborators

University of California, San Francisco

Western Trauma Association

Novo Nordisk

American Association for the Surgery of Trauma

Investigators

Principal Investigator:

Margaret Knudson, MD

University of California, San Francisco

More Information

No publications provided

Study ID Numbers:	H6693-27309-01
Study First Received:	May 17, 2006
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00328133 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

recombinant Factor VIIa
traumatic hemorrhage
hemorrhagic shock
coagulopathy

Study placed in the following topic categories:

Shock
Blood Coagulation Disorders
Wounds and Injuries

Hemorrhage
Hemostatic Disorders
Shock, Hemorrhagic

Additional relevant MeSH terms:

Pathologic Processes
Shock
Hemorrhage
Shock, Hemorrhagic

ClinicalTrials.gov processed this record on September 11, 2009