Intraventricular Hemorrhage Thrombolysis Trial "ITT"

Completed

Phase 2 Results

Trial Description

To assess the efficacy of intraventricular thrombosis in patients with intraventricular hemorrhage (IVH).

Interventions

Trial Design

Prospective, randomized, double-blinded, placebo-controlled, multicenter clinical trial.

Patient Involvement

All patients will undergo EVD. Patients in the treatment group will also receive 1-3 mg r-tPA injected into the ventricles 1 hour before the commencement of drainage, and twice daily thereafter. Patients in the placebo group will receive injections of Ringer's lactate on the same time scale. Participants will receive daily head CT scans during the acute treatment phase, and again between days 28 and 32.

Outcomes

Type Measure Time Frame Safety Issue
Primary Percent rate of intraventricular blood clot resolution.
Secondary Duration of external ventricular drainage, degree and incidence of communicating hydrocephalus at 30 days.

Sponsors

Orphan Products Development Division of the FDA