NCT00029315

Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage

Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Cerebral Hemorrhage

Interventions

Type	Name	Description
DRUG	Recombinant Tissue Plasminogen Activator (rt-PA)

Timeline

• Start date: 2001-09-01
• Completion: 2004-09-01
• First posted: 2002-01-11
• Last updated: 2015-03-25

Locations

1 site across 1 country: United States