Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, December 2001

First Received: January 10, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

Drug Information available for: Alteplase Tissue-type plasminogen activator

U.S. FDA Resources

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

FDA Office of Orphan Products Development

More Information

No publications provided

Study ID Numbers:	FD-R-2018-01, FD-R-002018-01
Study First Received:	January 10, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00029315 History of Changes
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

Additional relevant MeSH terms:

Cerebral Hemorrhage
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Cardiovascular Agents
Intracranial Hemorrhages

Hemorrhage
Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Fibrin Modulating Agents
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Plasminogen

ClinicalTrials.gov processed this record on February 08, 2010