Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study

Conditions
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Cerebral Hemorrhage

Intervention / Treatment
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* Drug: Recombinant Tissue Plasminogen Activator (rt-PA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Recombinant Tissue Plasminogen Activator (rt-PA)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Ventricles, Intraventricular hemorrhage, Subarachnoid hemorrhage, Intracerebral hemorrhage, Pharmacokinetics, Recombinant Proteins, Anticoagulants, Tissue Plasminogen Activator, Pharmacology, Catheters, Indwelling