title: Early surgical treatment for supratentorial intracerebral hemorrhage: a randomized feasibility study.
abstract: OBJECTIVE
  The safety and the effectiveness of the surgical treatment of spontaneous intracerebral hemorrhage (ICH) remain controversial. To investigate the feasibility of urgent surgical evacuation of ICH, we conducted a small, randomized feasibility study of early surgical treatment versus current nonoperative management in patients with spontaneous supratentorial ICH.
  
  
  METHODS
  Patients with spontaneous supratentorial ICH who presented to 1 university and 2 community hospitals were randomized to surgical treatment or best medical treatment. Principal eligibility criteria were ICH volume >10 cm(3) on baseline CT scan with a focal neurological deficit, Glasgow Coma Scale score >4 at the time of enrollment, randomization and therapy within 24 hours of symptom onset, surgery within 3 hours of randomization, and no evidence for ruptured aneurysm or arteriovenous malformation. The primary end point was the 3-month Glasgow Outcome Scale (GOS). A good outcome was defined as a 3-month GOS score >3.
  
  
  RESULTS
  Twenty patients were randomized over 24 months, 9 to surgical intervention and 11 to medical treatment. The median time from onset of symptoms to presentation at the treating hospitals was 3 hours and 17 minutes, the time from randomization to surgery was 1 hour and 20 minutes, and the time from onset of symptoms to surgery was 8 hours and 35 minutes. The likelihood of a good outcome (primary outcome measure: GOS score >3) for the surgical treatment group (56%) did not differ significantly from the medical treatment group (36%). There was no significant difference in mortality at 3 months. Analysis of the secondary 3-month outcome measures showed a nonsignificant trend toward a better outcome in the surgical treatment group versus the medical treatment group for the median GOS, Barthel Index, and Rankin Scale and a significant difference in the National Institutes of Health Stroke Scale score (4 versus 14; P=0.04).
  
  
  CONCLUSIONS
  Very early surgical treatment for acute ICH is difficult to achieve but feasible at academic medical centers and community hospitals. The trend toward less 3-month morbidity with surgical intervention in patients with spontaneous supratentorial ICH warrants further investigation of very early clot removal in larger randomized clinical trials.
authors.affiliation: Department of Neurosurgery, University of Cincinnati Medical Center Ohio 45267-0525, USA.
authors.forename: M
authors.initials: M
authors.lastname: Zuccarello
authors.forename: T
authors.initials: T
authors.lastname: Brott
authors.forename: L
authors.initials: L
authors.lastname: Derex
authors.forename: R
authors.initials: R
authors.lastname: Kothari
authors.forename: L
authors.initials: L
authors.lastname: Sauerbeck
authors.forename: J
authors.initials: J
authors.lastname: Tew
authors.forename: H
authors.initials: H
authors.lastname: Van Loveren
authors.forename: H S
authors.initials: HS
authors.lastname: Yeh
authors.forename: T
authors.initials: T
authors.lastname: Tomsick
authors.forename: A
authors.initials: A
authors.lastname: Pancioli
authors.forename: J
authors.initials: J
authors.lastname: Khoury
authors.forename: J
authors.initials: J
authors.lastname: Broderick
mesh_terms: D002526:Cerebellar Diseases / Q000188:drug therapy / Q000401:mortality / Q000601:surgery*; D002543:Cerebral Hemorrhage / Q000188:drug therapy / Q000401:mortality / Q000601:surgery*; D003399:Craniotomy; D005240:Feasibility Studies; D006801:Humans; D007431:Intraoperative Complications; D011183:Postoperative Complications; D013238:Stereotaxic Techniques; D016896:Treatment Outcome