CLINICAL STUDIES HUMAN RECOMBINANT FACTOR VII FOR EMERGENCY REVERSAL OF COAGULOPATHY IN NEUROSURGICAL PATIENTS:ARETROSPECTIVE COMPARATIVE STUDY Ben Roitberg, M.D. Department of Neurosurgery, University of Illinois at Chicago, Chicago, Illinois Obinna Emechebe- Kennedy, Pharm.D. Department of Neurosurgery, University of Illinois at Chicago, Chicago, Illinois Sepideh Amin-Hanjani, M.D. Department of Neurosurgery, University of Illinois at Chicago, Chicago, Illinois Jeffrey Mucksavage, Pharm.D. Department of Neurosurgery, University of Illinois at Chicago, Chicago, Illinois Eljim Tesoro, Pharm.D. Department of Neurosurgery, University of Illinois at Chicago, Chicago, Illinois Reprint requests: Ben Roitberg, M.D., Department of Neurosurgery, University of Illinois at Chicago, MC 799, 912 S. Wood Street, Chicago, IL 60612. Email: roitberg@uic.edu Received, December 2, 2004. Accepted, June 9, 2005. OBJECTIVE: Severe coagulopathy in a neurosurgical patient with intracranial hemor- rhage is a common and serious problem. Current therapy with vitamin K and fresh- frozen plasma (FFP) may be too slow in certain situations. There are reports of rapid reversal of coagulopathy using human recombinant factor VII. We present a retrospec- tive controlled study of our experience with factor VII. METHODS: We used factor VII as a second-line therapy after initial attempts at reversal with FFP had failed. Factor VII was given to 29 patients in the neurosurgical intensive care unit; 24 patients treated before the introduction of factor VII were control subjects. The groups were matched by age, sex, cause of coagulopathy, and presence of intracranial hemorrhage. RESULTS: After initial FFP administration, the international normalized ratio (INR) changed from a mean of 2.57 to 1.67 in the factor VII group and from 2.17 to 1.85 in control subjects. In all patients, INR tended to rebound. Before administration of factor VII, the mean INR was 2.206. After 1.4 mg of factor VII, mean INR decreased to 1.12 (P  0.05). Measured from admission, INR in the factor VII group normalized within 6.78  2.68 hours, and in control subjects, within 47.44  9.88 hours (P  0.0005). Six factor VII patients and six control subjects died. The number of patients with good functional outcome (Glasgow Outcome Scale score of 5) was greater among patients treated with factor VII compared with those who received only vitamin K and FFP (nine versus two, P = 0.04). None of the deaths were the result of a thrombotic complica- tion. There were no thrombotic complications in the factor VII group. CONCLUSION: Factor VII is safe and highly effective when emergency reversal of coagulopathy is desired and may improve the functional outcome. We speculate that the use of factor VII as first choice may result in decreased use of FFP and thus increase patient safety. KEY WORDS: Coagulopathy, Recombinant activated factor VII, Treatment Neurosurgery 57:832-836, 2005 DOI: 10.1227/01.NEU.0000180816.80626.C2 www.neurosurgery-online.com N eurosurgeons often must treat pa- tients with coagulopathy, which may be the result of diverse causes, such as liver disease or pharmacological anticoagula- tion with warfarin. The patients may be expe- riencing intracranial hemorrhage (ICH) or have another neurological compromise that must be treated surgically. Coagulation must be rapidly restored in these patients to save their life and function and to make surgical intervention possible. This is usually achieved by the administration of phytonadione (vita- min K) and infusion of fresh-frozen plasma (FFP). Both treatments are suboptimal. Vita- min K acts slowly and may not be effective in liver failure; FFP infusion takes time, requires administration of a large volume of what is essentially a colloid solution, and carries the risk of disease transmission. The use of recom- binant activated factor VII (rFVIIa) to correct a coagulopathy before neurosurgical interven- tion was reported in 1998 in a hemophiliac patient with an epidural hematoma requiring craniotomy for evacuation (5). In early 2001, we decided to introduce factor VII in our prac- tice in selected cases. At that time, we were 832 | VOLUME 57 | NUMBER 5 | NOVEMBER 2005 www.neurosurgery-online.com