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

NCT ID: NCT00328133

Last Updated: 2012-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 380 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2011-06-30

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.

Conditions

Traumatic Hemorrhage; Hemorrhagic Shock

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

Coagulopathy treated with rFVIIa

Exclusion Criteria

none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Trauma Association

OTHER

Sponsor Role: collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

American Association for the Surgery of Trauma

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Knudson, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco, San Francisco General Hospital

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21115374 (View on PubMed)

Other Identifiers

H6693-27309-01

Identifier Type: -

Identifier Source: org_study_id