Early surgical treatment for supratentorial intracerebral hemorrhage - A randomized feasibility study

Background and Purpose-The safety and the effectiveness of the surgical tre atment of spontaneous intracerebral hemorrhage (ICH) remain controversial. To investigate the feasibility of urgent surgical evacuation of ICH, we con ducted a small, randomized feasibility study of early surgical treatment ve rsus current nonoperative management in patients with spontaneous supratent orial ICH. Methods-Patients with spontaneous supratentorial ICH who presented to 1 uni versity 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 S cale score >4 at the time of enrollment, randomization and therapy within 2 4 hours of symptom onset, surgery within 3 hours of randomization, and no e vidence for ruptured aneurysm or arteriovenous malformation. The primary en d point was the 3-month Glasgow Outcome Scale (GOS). A good outcome was def ined as a 3-month GOS score >3. Results-Twenty patients were randomized over 24 months, 9 to surgical inter vention 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 likelihoo d of a good outcome (primary outcome measure: GOS score >3) for the surgica l treatment group (56%) did not differ significantly from the medical treat ment group (36%). There was no significant difference in mortality at 3 mon ths. Analysis of the secondary 3-month outcome measures showed a nonsignifi cant trend toward a better outcome in the surgical treatment group versus t he medical treatment group for the median GOS, Barthel Index, and Rankin Sc ale and a significant difference in the National Institutes of Health Strok e Scale score (4 versus 14; P=0.04). Conclusions-Very early surgical treatment for acute ICH is difficult to ach ieve 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.