Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 75
Updated:3/16/2015
Start Date:September 2001
End Date:September 2003

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Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study

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.

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.

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
We found this trial at
1
site
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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