drugset / Trial / NCT01098890

Intraventricular Tissue Plasminogen Activator (tPA) in the Management of Aneurysmal Subarachnoid Hemorrhage

NCT01098890

Phase 2 Unknown 12 enrolled University of Calgary
RandomizedSingle-groupQuadruple-blindTreatment

Summary

The proposed study is to evaluate the acceleration the clearance of intraventricular blood (IVH) and subarachnoid hemorrhage (SAH) following ruptured intracranial aneurysms, thereby ameliorating complications, such as cerebral vasospasm, hydrocephalus and intracranial hypertension. The primary objectives are: 1. Estimate the rate and variance of hematoma clearance following aneurysmal SAH, thereby facilitating sample size determination for a subsequent larger study; 2. Assess the feasibility of a randomized controlled trial of intraventricular tissue plasminogen activator (TPA) among patients with SAH (enrollment rate, ability to blind investigators, protocol compliance); 3. Confirm the safety of intraventricular TPA.

Timeline

Start
2009-10
Primary completion
2011-10
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alteplase Protein / enzyme biologic 2 mg Intrathecal