Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage
Information source: FDA Office of Orphan Products Development
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebral Hemorrhage
Intervention: Recombinant Tissue Plasminogen Activator (rt-PA) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: FDA Office of Orphan Products Development
Summary
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.
Clinical Details
Official title: Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Pharmacokinetics/Dynamics Study
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
The Johns Hopkins University, Baltimore, Maryland 21287, United States; Recruiting
Daniel F. Hanley, M.D., Phone: 410-614-6996, Email: dhanley@jhmi.edu
Additional Information
Starting date: September 2001
Ending date: September 2003
Last updated: June 23, 2005
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