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Randomized Controlled Trial Comparative Study Clinical Trial
Surgical treatment for intracerebral hemorrhage (STICH): a single-center, randomized clinical trial.
- L B Morgenstern, R F Frankowski, P Shedden, W Pasteur, and J C Grotta.
- Department of Neurology, The University of Texas Medical School at Houston, 77030, USA.
- Neurology. 1998 Nov 1;51(5):1359-63.
ObjectiveTo perform a single-center pilot investigation of early hematoma removal in patients with intracerebral hemorrhage (ICH).BackgroundConsiderable debate remains regarding the utility of surgical clot evacuation for ICH.MethodsThis was a prospective trial of open craniotomy within 12 hours of ICH symptom onset versus best medical therapy. Patients were eligible if they had a nontraumatic ICH >9 mL with significant neurologic impairment and were prepared for surgery within 12 hours of symptom onset. The study included a prospective registry of patients and a randomized trial.ResultsThe registry group included 34 medical and seven surgical patients. The surgical group had larger hemorrhages (median, 96 mL) and a lower Glasgow Coma Scale (GCS) score (median, 10) compared with the medical group (33 mL; GCS score, 13). Six-month mortality was less in the medical group (36%) compared with the surgical group (54%). In the randomized series, median ICH volumes were similar in the surgical group (n = 17; 49 mL) compared with the medical group (n = 17; 44 mL). Median GCS score was also similar (medical, 10; surgical, 11). Mortality was lower in the surgical group (6%) compared with the medical group (24%) at 1 month, but similar at 6 months (surgical group, 17%; medical group, 24%).ConclusionA trial of early surgery for ICH is feasible. This study represents the largest prospective, randomized series of surgery for ICH. A modest early mortality benefit for surgery is possible, but long-term benefit for surgery was not established in this single-center pilot investigation.
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