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Previous Volume 352:777-785 February 24, 2005 Number 8 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Brown, D. L. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Intracerebral hemorrhage is the least treatable form of stroke and is associated with high mortality. Among patients who undergo computed tomography (CT) within three hours after the onset of intracerebral hemorrhage, one third have an increase in the volume of the hematoma related to subsequent bleeding. We sought to determine whether recombinant activated factor VII (rFVIIa) can reduce hematoma growth after intracerebral hemorrhage.

Methods We randomly assigned 399 patients with intracerebral hemorrhage diagnosed by CT within three hours after onset to receive placebo (96 patients) or 40 µg of rFVIIa per kilogram of body weight (108 patients), 80 µg per kilogram (92 patients), or 160 µg per kilogram (103 patients) within one hour after the baseline scan. The primary outcome measure was the percent change in the volume of the intracerebral hemorrhage at 24 hours. Clinical outcomes were assessed at 90 days.

Results Hematoma volume increased more in the placebo group than in the rFVIIa groups. The mean increase was 29 percent in the placebo group, as compared with 16 percent, 14 percent, and 11 percent in the groups given 40 µg, 80 µg, and 160 µg of rFVIIa per kilogram, respectively (P=0.01 for the comparison of the three rFVIIa groups with the placebo group). Growth in the volume of intracerebral hemorrhage was reduced by 3.3 ml, 4.5 ml, and 5.8 ml in the three treatment groups, as compared with that in the placebo group (P=0.01). Sixty-nine percent of placebo-treated patients died or were severely disabled (as defined by a modified Rankin Scale score of 4 to 6), as compared with 55 percent, 49 percent, and 54 percent of the patients who were given 40, 80, and 160 µg of rFVIIa, respectively (P=0.004 for the comparison of the three rFVIIa groups with the placebo group). Mortality at 90 days was 29 percent for patients who received placebo, as compared with 18 percent in the three rFVIIa groups combined (P=0.02). Serious thromboembolic adverse events, mainly myocardial or cerebral infarction, occurred in 7 percent of rFVIIa-treated patients, as compared with 2 percent of those given placebo (P=0.12).

Conclusions Treatment with rFVIIa within four hours after the onset of intracerebral hemorrhage limits the growth of the hematoma, reduces mortality, and improves functional outcomes at 90 days, despite a small increase in the frequency of thromboembolic adverse events.

Source Information

From the Departments of Neurology and Neurosurgery, Columbia University College of Physicians and Surgeons, New York (S.A.M.); Novo Nordisk, Bagsvaerd, Denmark (N.C.B., K.B.); the University of Cincinnati Medical Center, Cincinnati ( J.B.); Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia (S.D.); Washington University School of Medicine, St. Louis (M.N.D.); Novo Nordisk, Princeton, N.J. (B.E.S.); and the University of Heidelberg, Heidelberg, Germany (T.S.).

Address reprint requests to Dr. Mayer at the Neurological Institute, 710 W. 168th St., Box 39, New York, NY 10032, or at sam14{at}columbia.edu.

Full Text of this Article

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Recombinant Activated Factor VII for Acute Intracerebral Hemorrhage
Friedrich J. O., Sheth K. N., Mayer S. A., Brun N. C.
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N Engl J Med 2005; 352:2133-2134, May 19, 2005. Correspondence

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