A MULTICENTER TRIAL OF THE EFFICACY OF NIMODIPINE ON OUTCOME AFTER SEVERE HEAD-INJURY

Between January 1, 1989, and June 30, 1991, 852 severely head-injured patients were entered into a prospective placebo-controlled trial of t he efficacy of nimodipine administration. The patients could not obey commands at the time of entry into the trial, which was within 12 hour s after the start of the inability to obey commands and within 24 hour s of injury. The main hypothesis that nimodipine would increase the pe rcentage of patients with a favorable outcome (moderate disability or good recovery) from 50% to 60% was rejected. A trend toward a favorabl e effect was seen in patients who exhibited traumatic subarachnoid hem orrhage (SAH) on the computerized tomography (CT) scan obtained prior to entry into the study. The effect was statistically significant in t hose patients who complied with all protocol requirements. This findin g is consistent with the effect of nimodipine on secondary ischemia fo llowing spontaneous SAH. The results of the study warrant a clinical t rial of the efficacy of nimodipine in severely head-injured patients w ho show traumatic SAH on the initial CT scan.