Clinical trial NCT00328133: The Use of rFVIIa in Trauma Patients: A Multi-Center Case Registry
Official title: The Use of rFVIIa in Trauma Patients: A WTA/AAST Multi-Center Case Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Hemorrhage
Hemorrhagic Shock
Keywords: recombinant Factor VIIa
traumatic hemorrhage
hemorrhagic shock
coagulopathy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Western Trauma Association
name: Novo Nordisk A/S
name: American Association for the Surgery of Trauma
First posted: 2006-05-19
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective and prospective observational case review study on traumatically injured adult patients.

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.

Eligibility criteria: Inclusion Criteria:

Coagulopathy treated with rFVIIa

Exclusion Criteria:

none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco, San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Margaret Knudson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.