- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00029315
Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage
Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- The Johns Hopkins University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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