Prevention of delayed ischemic deficits after aneurysmal subarachnoid hemorrhage by intrathecal bolus injection of tissue plasminogen activator

Completed

Phase N/A Results

Trial Description

To examine the efficacy of a single bolus injection of rtPA in the prevention of delayed ischemic deficits after aneurysmal subarachnoid hemorrhage.

Interventions

Trial Design

Prospective, non-randomized, controlled trial of 120 patients at a single center.

Patient Involvement

In all patients the aneurysm was clipped using standard microsurgical techniques. After the aneurysm had been excluded from the parent vessel, 10 mg of rtPA, dissolved in 10 ml of its solution fluid, were slowly instilled into the basal cisterns in the treatment group. In patients with additional severe intraventricular bleeding, 5-10 mg of rtPA were injected into the ventricles via an intraventricular catheter at the end of the operation. Apart from the intrathecal application of the thrombolytic substance, the surgical protocol was identical in the patients of the control group. During the postoperative period, the patients in both groups were examined neurologically and by transcranial Doppler on a daily basis. Final clinical grading was done three months after surgery according to the Glasgow Outcome Scale.

Outcomes

Type Measure Time Frame Safety Issue
Primary Occurrence of clinical signs of delayed ischemic deficits (DID), attributable to the occurrence of cerebral vasospasm.