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Intraventricular rt-PA in Patients with Intraventricular Hemorrhage
This study is currently recruiting patients.
Sponsored by: | FDA Office of Orphan Products Development |
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Information provided by: | FDA Office of Orphan Products Development |
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 | Treatment or Intervention | Phase |
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Cerebral Hemorrhage |
Drug: Recombinant Tissue Plasminogen Activator (rt-PA) |
Phase II |
MedlinePlus related topics: Stroke
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Pharmacokinetics/Dynamics Study
Official Title: Intraventricular rt-PA Pharmacokinetic and Pharmacodynamic Study
Expected Total Enrollment: 30
Study start: September 2001;
Study completion: September 2003
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 - 75 Years, Genders Eligible for Study: Both
Criteria
Inclusion criteria:
Exclusion criteria:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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