BACKGROUND AND PURPOSE: To date, there are no proven, effective treatments for intracerebral hemorrhage (ICH) beyond supportive medical care. A recent randomized, blinded, placebo-controlled trial of recombinant factor VIIa (rFVIIa) administered intravenously within 4 hours of ICH onset reported a reduction in morbidity and mortality compared with placebo. We sought to determine the potential applicability of rFVIIa in a large, population-based cohort of ICH patients. METHODS: All of the patients age > or =18 years hospitalized with nontraumatic ICH in the Greater Cincinnati region were identified from May 1998 to July 2001 and August 2002 to April 2003. Patient demographics were compared with the inclusion and exclusion criteria from the rFVIIa trial to determine eligibility for treatment and reasons for exclusion. Mortality in the eligible patient group was compared with the placebo group in the rFVIIa trial. RESULTS: Over 4 calendar years, 1018 ICH patients were identified; of these, 133 (13.1%) had no exclusions and presented within the prescribed time window. An additional 45 patients (4.4%) may have been eligible but had uncertain onset or computed tomography scan times. The most common reasons for exclusion (not mutually exclusive) were late presentation (n=398), vaso-occlusive disease (n=369), deep coma (n=219), and prolonged international normalized ratio or partial thromboplastin time (n=200). Mortality at 90 days among potentially eligible patients was the same as for the placebo group in the rFVIIa trial (29% versus 29%; P=0.99). CONCLUSIONS: In this large, population-based ICH cohort, 13.1% to 17.5% of patients would have qualified for treatment with rFVIIa by trial criteria.
RCT Entities:
BACKGROUND AND PURPOSE: To date, there are no proven, effective treatments for intracerebral hemorrhage (ICH) beyond supportive medical care. A recent randomized, blinded, placebo-controlled trial of recombinant factor VIIa (rFVIIa) administered intravenously within 4 hours of ICH onset reported a reduction in morbidity and mortality compared with placebo. We sought to determine the potential applicability of rFVIIa in a large, population-based cohort of ICHpatients. METHODS: All of the patients age > or =18 years hospitalized with nontraumatic ICH in the Greater Cincinnati region were identified from May 1998 to July 2001 and August 2002 to April 2003. Patient demographics were compared with the inclusion and exclusion criteria from the rFVIIa trial to determine eligibility for treatment and reasons for exclusion. Mortality in the eligible patient group was compared with the placebo group in the rFVIIa trial. RESULTS: Over 4 calendar years, 1018 ICHpatients were identified; of these, 133 (13.1%) had no exclusions and presented within the prescribed time window. An additional 45 patients (4.4%) may have been eligible but had uncertain onset or computed tomography scan times. The most common reasons for exclusion (not mutually exclusive) were late presentation (n=398), vaso-occlusive disease (n=369), deep coma (n=219), and prolonged international normalized ratio or partial thromboplastin time (n=200). Mortality at 90 days among potentially eligible patients was the same as for the placebo group in the rFVIIa trial (29% versus 29%; P=0.99). CONCLUSIONS: In this large, population-based ICH cohort, 13.1% to 17.5% of patients would have qualified for treatment with rFVIIa by trial criteria.
Authors: Joshua N Goldstein; Louis E Fazen; Lauren Wendell; Yuchiao Chang; Natalia S Rost; Ryan Snider; Kristin Schwab; Rishi Chanderraj; Christopher Kabrhel; Catherine Kinnecom; Emilie Fitzmaurice; Eric E Smith; Steven M Greenberg; Jonathan Rosand Journal: Neurocrit Care Date: 2008-09-23 Impact factor: 3.210
Authors: H Bart Brouwers; Yuchiao Chang; Guido J Falcone; Xuemei Cai; Alison M Ayres; Thomas W K Battey; Anastasia Vashkevich; Kristen A McNamara; Valerie Valant; Kristin Schwab; Susannah C Orzell; Linda M Bresette; Steven K Feske; Natalia S Rost; Javier M Romero; Anand Viswanathan; Sherry H-Y Chou; Steven M Greenberg; Jonathan Rosand; Joshua N Goldstein Journal: JAMA Neurol Date: 2014-02 Impact factor: 18.302
Authors: Farhan Siddiq; Abdul Jalil; Cara McDaniel; David G Brock; Carissa C Pineda; Rodney D Bell; Kiwon Lee Journal: Neurocrit Care Date: 2008 Impact factor: 3.210