Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage

NCT ID: NCT00029315

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2004-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Recombinant Tissue Plasminogen Activator (rt-PA)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Intraventricular hemorrhage (IVH) confirmed by CT scan
• More than 12 hours post bleed
• Hematoma size stable by CT scan
• Post-IVH catheter CT scan
• Able to begin study within 24 hours of bleed

Exclusion Criteria

• Infratentorial bleed
• Supratentorial bleed greater than 30 cc
• Unclipped aneurysm suspected
• Arteriovenous malformation suspected
• Any severe, complicating illness (e.g., AIDS or DNR)
• Cardiovascular parameters that could confound study (e.g., myocardial infarction, pulmonary emboli, systemic fibrinolysis)
• Active internal bleeding
• Requirement for heparin doses greater than 10,000 U/day
• Concurrent coumadin
• Known allergy to rt-PA
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Locations

The Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

FD-R-002018-01

Identifier Type: -

Identifier Source: secondary_id

FD-R-2018-01

Identifier Type: -

Identifier Source: org_study_id