Intravenous nimodipine in the treatment of cerebral vasospasm following subarachnoid hemorrhage caused by aneurysm rupture

Completed

Phase N/A Results

Trial Description

To investigate the therapeutic efficacy of intravenous nimodipine in the treatment of delayed ischemic deterioration or angiographic vasospasm after subarachnoid hemorrhage caused by a ruptured aneurysm.

Interventions

  • Nimodipine (NimotopĀ®)Drug
    Intervention Desc: Calcium channel blocker (L-type calcium channels)

Trial Design

Randomized, double-blind, placebo-controlled, trial of 188 patients at 13 centers.

Patient Involvement

Patients were randomized to receive intravenous nimodipine (2 mg/h) or placebo. Treatment was initiated within 24 hours of delayed ischemic deterioration (DID) connected with vasospasm or of an arteriogram that had revealed vasospasm and within 25 days of first hemorrhage. Treatment was continued for a minimum of 7 days and a maximum of 14 days depending on the stability of the patient condition. Infusion was maintained for at least 3 days postoperatively if surgical intervention took place.

Outcomes

Type Measure Time Frame Safety Issue
Primary Combined number of deaths and cases of severe neurological deficit (measured by Glasgow Outcome Scale) related to vasospasm as assessed at discharge.
Secondary Mortality alone, severe morbidity alone.