Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage

Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Hemorrhage
• Intervention / Treatment: Drug: Recombinant Tissue Plasminogen Activator (rt-PA)

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: Double

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Study Completion: September 1, 2004

Study Registration Dates

• First Submitted: January 10, 2002
• First Submitted That Met QC Criteria: January 10, 2002
• First Posted (Estimate): January 11, 2002

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: December 1, 2001

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Subarachnoid hemorrhage; Recombinant Proteins; Pharmacology; Anticoagulants; Catheters, Indwelling; Intraventricular hemorrhage; Intracerebral hemorrhage; Tissue Plasminogen Activator; Cerebral Ventricles
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator; Plasminogen
• Other Study ID Numbers: FD-R-2018-01; FD-R-002018-01