Clinical Trials

Although many surgeons historically believed that surgical evacuation is indicated in those patients with large- and moderate-sized ICH, as stated earlier, the benefits of surgical evacuation have not been proven with a randomized, controlled trial. In 1961, in the first prospective, randomized, controlled trial that compared surgical treatment with medical management, the authors (18) reported that operative treatment was associated with a worse outcome than conservative treatment for patients with spontaneous supratentorial ICH. In 1989, opposite results were reported in a trial of endoscopic removal of hemorrhage in 100 patients (19). However, a different 1989 study reported results that supported the results of the 1961 study (20). Further trials have since been completed, and none has reported any firm conclusions regarding the role of operative treatment in the management of patients with an ICH (21).

Recently, a large International Surgical Trial in Intracerebral Hemorrhage (STICH) was conducted to assess whether a policy of early surgical evacuation of the hematoma in patients with spontaneous supratentorial ICH would improve outcome, in terms of death and disability, compared with a policy of initial conservative treatment (3). This study included 1033 patients from 83 centers in 27 countries, who were randomized to early surgery (503) or initial conservative treatment (530). At 6 months, 51 patients were lost to follow-up, and 17 were alive with unknown status. Of 468 patients randomized to early surgery, 122 (26%) had a favorable outcome, compared with 118 (24%) of 496 patients randomized to initial conservative treatment. These results demonstrated that patients with spontaneous supratentorial ICH in neurosurgi-cal units show no overall benefit from early surgery when compared with initial conservative treatment (3). Results from one subset of patients, however, did favor surgery in patients with hematomas that were <1 cm from the cortical surface. These patients were more likely to have a favorable outcome from early surgery than those who received medical management. The clearest and most disappointing result was the uniformly poor outcome in patients presenting with ICH in coma.

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