Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage

Cerebral Hemorrhage Clinical Trial

Official title:

Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029315
• Other study ID #: FD-R-2018-01
• Secondary ID: FD-R-002018-01
• Status: Completed
• Phase: Phase 2
• First received: January 10, 2002
• Last updated: March 24, 2015
• Start date: September 2001
• Est. completion date: September 2004

Study information

• Verified date: December 2001
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage

Intervention

Drug:
• Recombinant Tissue Plasminogen Activator (rt-PA)

Locations

Country	Name	City	State
United States	The Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States,