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(Stroke. 2008;39:473.)
© 2008 American Heart Association, Inc.

Research Letters

The Effect of Activated Factor VII for Intracerebral Hemorrhage Beyond 3 Hours Versus Within 3 Hours

Hen Hallevi, MD; Nicole R. Gonzales, MD; Andrew D. Barreto, MD; Sheryl Martin-Schild, MD, PhD; Karen C. Albright, DO, MPH; Elizabeth A. Noser, MD; Kachi Illoh, MD; Aslam M. Khaja, MD; Teresa Allison, PharmD; Miguel A. Escobar, MD; Hashem M. Shaltoni, MD James C. Grotta, MD

From the Department of Neurology (H.H., N.R.G., A.D.B., S.M.-S., E.A.N., K.I., A.M.K., H.M.S., J.C.G.), University of Texas at Houston Medical School, Houston, Tex; Mayo Clinic (K.C.A.), Jacksonville, Fla; Department of Pharmacy (T.A.), Memorial Hermann Texas Medical Center, Houston, Tex; Department of Hematology (M.A.E.), University of Texas Health Sciences Center, Houston, Tex.

Correspondence to Hen Hallevi, Vascular Neurology Program, Department of Neurology, University of Texas Health Science Center at Houston, 6431 Fannin St, MSB 7.044, Houston, TX 77030. E-mail hen.hallevi{at}uth.tmc.edu

Abstract

Background and Purpose— Recombinant-activated factor VII (rFVIIa) is an investigational treatment for intracerebral hemorrhage (ICH). We have evaluated the drug’s treatment effect based on time to treatment.

Methods— ICH patients treated up to 4 hours from symptom onset were divided based on time to treatment: 3 hours (3H) and 3 to 4 hours (4H). Head CT was done at baseline and 24 hours. Outcome measures included: ICH growth at 24 hours, mortality, favorable outcome and discharge disposition. A cohort of nontreated matched ICH patients was used to asses the clinical efficacy.

Results— Forty-six patients were treated with rFVIIa: 24 in the 3H group (range 70 to 180 minutes), 22 in the 4H group (range 181 to 300). One hundred and forty-eight patients formed the control group. Mean baseline ICH volume was 8.8 mL for 3H and 10.1 mL for 4H. Mean 24-hour volume was 9.3 mL for 3H (absolute increase 1.05 mL, relative increase 11.9%) and 11.5 mL for 4H (absolute increase 1.1 mL, relative increase 10.9%); P=0.47 is for the difference in relative increase. Mortality was 12.5% for 3H group, 13.6% for 4H, and 13.1% for the control. In the 3H group, 58.3% were discharged with a poor outcome, compared with 54.5% in 4H and 54.1% in the control. Thrombotic adverse events occurred in 11.1% of patients treated with rFVIIa.

Conclusions— In our off-label with rFVIIa, we did not find evidence of a treatment effect based on time to treatment. Other criteria should be sought to identify patients who might benefit clinically from rFVIIa.

Key Words: hematoma growth • intracerebral hemorrhage • recombinant-activated factor VII