drugset / Trial / NCT01098890
Intraventricular Tissue Plasminogen Activator (tPA) in the Management of Aneurysmal Subarachnoid Hemorrhage
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alteplase | Protein / enzyme biologic | 2 mg | Intrathecal |