Thromboembolic complications associated with factor VIIa administration.
BACKGROUND
Factor VIIa (FVIIa) is given to promote hemostasis in coagulopathic trauma patients at high risk for death. FVIIa is associated with thromboembolic complications, but the incidence is not known, nor is which patients are at risk. We examined our experience with FVIIa to better understand this issue.


METHODS
Medical records of patients who received FVIIa from 2001 to 2006 were reviewed for evidence of thromboembolic events, including ischemic cardiovascular accident, myocardial ischemia or infarct, mesenteric infarct, peripheral arterial thromboembolism, deep venous thrombosis, or pulmonary embolus. Indication for FVIIa dosing, timing of complication, and clinical outcome were recorded. Each event was assessed by a panel of experienced clinicians to determine the contribution of FVIIa to the event and to patient outcome.


RESULTS
Two hundred eighty-five medical records were reviewed. Twenty-seven patients (9.4%) had thromboembolic complications after administration of FVIIa. Nine events were thought to be highly related to FVIIa, and 10 of 14 deaths were, in part, caused by the thrombotic complication. Eighteen of the events, including all cardiovascular accidents and most cases of mesenteric ischemia, were attributed to a combination of FVIIa and a definable, high-energy vascular injury.


CONCLUSIONS
FVIIa is a potent procoagulant, with the potential for adverse thromboembolic events in susceptible patients. Our experience suggests that caution should be exercised in administration of FVIIa to patients with arterial injuries. Injured mesenteric and cerebral vessels may be especially susceptible to thrombosis.
Thomas
G O Rhys
GO
R. Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, MD 21201, USA.
Dutton
Richard P
RP
Hemlock
Bethany
B
Stein
Deborah M
DM
Hyder
Mary
M
Shere-Wolfe
Roger
R
Hess
John R
JR
Scalea
Thomas M
TM
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001778:Blood Coagulation Disorders / Q000188:drug therapy / Q000209:etiology; D001930:Brain Injuries / Q000188:drug therapy; D015942:Factor VIIa / Q000009:adverse effects*; D005260:Female; D006801:Humans; D015601:Injury Severity Score; D008297:Male; D008875:Middle Aged; D012771:Shock, Hemorrhagic / Q000188:drug therapy; D013923:Thromboembolism / Q000139:chemically induced*; D014947:Wounds and Injuries / Q000097:blood
D015942:Factor VIIa