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

Study 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.