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Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage

This study is currently recruiting participants.
Verified by FDA Office of Orphan Products Development, December 2001

Sponsored by: FDA Office of Orphan Products Development
Information provided by: FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier: NCT00029315
  Purpose

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.


Condition Intervention Phase
Cerebral Hemorrhage
Drug: Recombinant Tissue Plasminogen Activator (rt-PA)
Phase II

ChemIDplus related topics:   Alteplase    Tissue-type plasminogen activator   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Pharmacokinetics/Dynamics Study
Official Title:   Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:   30
Study Start Date:   September 2001
Estimated Study Completion Date:   September 2003

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.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029315

Locations
United States, Maryland
The Johns Hopkins University     Recruiting
      Baltimore, Maryland, United States, 21287
      Contact: Daniel F. Hanley, M.D.     410-614-6996     dhanley@jhmi.edu    

Sponsors and Collaborators
  More Information


Study ID Numbers:   FD-R-2018-01, FD-R-002018-01
First Received:   January 10, 2002
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00029315
Health Authority:   United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:
Intraventricular hemorrhage  
Subarachnoid hemorrhage  
Intracerebral hemorrhage  
Pharmacokinetics  
Recombinant Proteins  
Anticoagulants
Tissue Plasminogen Activator
Pharmacology
Catheters, Indwelling
Cerebral Ventricles

Study placed in the following topic categories:
Cerebral Hemorrhage
Vascular Diseases
Subarachnoid Hemorrhage
Tissue Plasminogen Activator
Central Nervous System Diseases
Intracranial Hemorrhages
Brain Diseases
Hemorrhage
Plasminogen
Cerebrovascular Disorders

Additional relevant MeSH terms:
Fibrin Modulating Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Nervous System Diseases
Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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