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| Sponsored by: |
FDA Office of Orphan Products Development |
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00029315 |
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 | Intervention | Phase |
|
Cerebral Hemorrhage |
Drug: Recombinant Tissue Plasminogen Activator (rt-PA) |
Phase II |
| ChemIDplus related topics: | Alteplase Tissue-type plasminogen activator |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Pharmacokinetics/Dynamics Study |
| Official Title: | Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2001 |
| Estimated Study Completion Date: | 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 to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| United States, Maryland | |||||
| The Johns Hopkins University | Recruiting | ||||
| Baltimore, Maryland, United States, 21287 | |||||
| Contact: Daniel F. Hanley, M.D. 410-614-6996 dhanley@jhmi.edu | |||||
More Information
| Study ID Numbers: | FD-R-2018-01, FD-R-002018-01 |
| First Received: | January 10, 2002 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00029315 |
| Health Authority: | United States: Food and Drug Administration |
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