Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage

Cerebral Hemorrhage Clinical Trial

Official title: Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study

Status Completed

Clinical Trial Summary

This is a study to evaluate how recombinant tissue plasminogen activator (rt-PA) is utilized in patients with intraventricular hemorrhage (IVH). rt-PA is a drug that has been shown to dissolve blood, and may allow intraventricular catheters to be more effective for a longer period of time.

Clinical Trial Description

IVH occurs in about 40 percent of intracerebral hemorrhage cases and 15 percent of aneurysmal subarachnoid hemorrhage cases. Evidence supports a strong contribution of IVH to morbidity and mortality after cerebral hemorrhage. External ventricular drainage (EVD) is required clinical management; however, EVD via intraventricular catheter alone fails to prevent much of the morbidity and mortality of IVH. This study seeks to demonstrate the safety and efficacy of intraventricular thrombolysis, using rt-PA, as a method of removing this blood and altering morbidity and mortality. Patients will receive intraventricular injections of rt-PA or placebo every 12 hours. They will be followed prospectively with daily head CT scans during the acute-treatment phase and again between Days 28 and 32.

Completion date provided represents the completion date of the grant per OOPD records ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage

• NCT number: NCT00029315
• Study type: Interventional
• Source: FDA Office of Orphan Products Development
• Status: Completed
• Phase: Phase 2
• Start date: September 2001
• Completion date: September 2004