Traumatic subarachnoid hemorrhage and its treatment with nimodipine. German tSAH Study Group.

A prospective, randomized, double-blind, placebo-controlled study of nimodipine used to treat traumatic subarachnoid hemorrhage (tSAH) was conducted in 21 German neurosurgical centers between January 1994 and April 1995. One hundred twenty-three patients with tSAH appearing on initial computerized tomography (CT) scanning were entered into the study. Requirements for inclusion included age between 16 and 70 and admission into the study within 12 hours after head injury, regardless of the patient's level of consciousness. Eligible patients received either a sequential course of intravenous and oral nimodipine or placebo treatment for 3 weeks. Patients were closely monitored using clinical neurology, computerized tomography, laboratory, and transcranial Doppler ultrasound parameters. Patients treated with nimodipine had a significantly less unfavorable outcome (death, vegetative survival, or severe disability) at 6 months than placebo-treated patients (25% vs. 46%, p = 0.02). The relative reduction in unfavorable outcome in the nimodipine-treated group was even higher (55%, p = 0.002) when only patients who complied with the protocol were considered.

RCT Entities:   Population Interventions Outcomes