Complications of recombinant activated human coagulation factor VII.
BACKGROUND
Recombinant factor VIIa (rFVIIa) frequently is used for treatment of life-threatening hemorrhage in trauma.


METHODS
A retrospective review of injured patients receiving rFVIIa at an American College of Surgeons-verified Level 1 trauma center was performed. Controls were matched for age, sex, Injury Severity Score, and traumatic brain injury. Thrombotic complications in patients administered rFVIIa, including deep venous thrombosis (DVT), pulmonary embolus, acute myocardial infarction, ischemic stroke, mesenteric ischemia, arterial thromboembolism, and death, were determined.


RESULTS
Thirty-six patients were given rFVIIa, of whom 5 (13.8%) had thrombotic complications. Indications for rFVIIa were life-threatening intracranial bleeding in the presence of pre-injury anticoagulation or hemorrhage. The incidences of DVT (n = 4) and acute myocardial infarction (n = 1) were noted. In the control group, there were fewer thrombotic complications (DVT, 1; pulmonary embolus, 1). The mortality rate (52.8%) was higher in patients receiving rFVIIa compared with the control group (22.2%; P = .014). Pre-injury anticoagulation was common in the treatment group.


CONCLUSIONS
Pre-injury anticoagulation is frequently the indication for rFVIIa administration. Thrombotic complications occur with rFVIIa administration. The mortality rate of injured patients who receive rFVIIa is high.
Howes
Jeremy L
JL
Department of Surgery, The University of Kansas School of Medicine-Wichita, KS, USA.
Smith
R Stephen
RS
Helmer
Stephen D
SD
Taylor
Scott M
SM
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015942:Factor VIIa / Q000009:adverse effects*; D005260:Female; D006470:Hemorrhage / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000009:adverse effects; D012189:Retrospective Studies; D020246:Venous Thrombosis / Q000139:chemically induced*; D014947:Wounds and Injuries / Q000150:complications; D055815:Young Adult
D011994:Recombinant Proteins; D015942:Factor VIIa