Dose Finding & Dose Frequency Determination Using rt-PA in Patients with Intraventricular Hemorrhage

Overview
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.

Purpose
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.

Eligibility

Inclusion criteria

  • Patient must have an intraventricular hemorrhage (IVH) confirmed by CT scan
  • Patient must be more than 12 hours post bleed
  • Patient must have a hematoma size stable by CT scan
  • Patient must have a post-IVH catheter CT scan
  • Patient must be able to begin study within 24 hours of bleed

Exclusion criteria

  • Patient must not have an infratentorial bleed
  • Patient must not have a supratentorial bleed greater than 30 cc
  • Patient must not have a suspected unclipped aneurysm
  • Patient must not have a suspected arteriovenous malformation
  • Patient must not have any severe, complicating illness (e.g., AIDS or DNR)
  • Patient must not have cardiovascular parameters that could confound study (e.g., myocardial infarction, pulmonary emboli, systemic fibrinolysis)
  • Patient must not have active internal bleeding
  • Patient must not have requirement for heparin doses greater than 10,000 U/day
  • Patient must not be taking concurrent coumadin
  • Patient must not have known allergy to rt-PA
  • Patient must not be pregnant

Study design
This is a Phase II randomized (double-blind, placebo control) study. 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.

Location & contact
Mario Zuccarello, MD (Principal investigator)
University of Cincinnati Medical Center
231 Albert Sabin Way
Cincinnati, OH 45219
Telephone: 513-558-3590
Fax: 513-558-7702
Email: suzanne.kempisty-cliver@uc.edu 

More information
More info is available for this study .
Start date: September, 2001
Close date: September 2003
Sponsor: NIH
Study ID number: FD-R-2018-01; FD-R-002018-01

 


Copyright © University of Cincinnati, 2004