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

NCT00328133 | Completed

• 1 other identifier: H6693-27309-01
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Hemorrhage; Hemorrhagic Shock

Keywords

recombinant Factor VIIa; traumatic hemorrhage; hemorrhagic shock; coagulopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective and prospective observational case review study on traumatically injured adult patients.

You may qualify if:

• Coagulopathy treated with rFVIIa

You may not qualify if:

• none

Sponsors & Collaborators

• University of California, San Francisco: lead
• Western Trauma Association: collaborator
• Novo Nordisk A/S: collaborator
• American Association for the Surgery of Trauma: collaborator

Study Sites (1)

University of California San Francisco, San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related 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;212(1):87-95. doi: 10.1016/j.jamcollsurg.2010.08.020. Epub 2010 Nov 5.

  PMID: 21115374 RESULT

MeSH Terms

Conditions

Shock, Hemorrhagic; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Margaret Knudson, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2006
• First Posted: May 19, 2006
• Study Start: June 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2011
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

US (1)