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Home > "I" Clinical Trials Conditions > Intraventricular rt-PA in Patients with Intraventricular Hemorrhage  Intraventricular rt-PA in Patients with Intraventricular Hemorrhage
Intraventricular rt-PA in Patients with Intraventricular Hemorrhage
For Condition: Cerebral Hemorrhage
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Pharmacokinetics/Dynamics Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 30
Location and Contact Information:
The Johns Hopkins University *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Daniel Hanley 410-614-6996
Additional Information:
Study ID Numbers: FD-R-2018-01; FD-R-002018-01
Study Start Date: September 2001
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029315
Other Cerebral Hemorrhage Studies:
1. Intraventricular rt-PA in Patients with Intraventricular Hemorrhage
Related Studies:
Other Cerebral Hemorrhage Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Intraventricular rt-PA in Patients with Intraventricular Hemorrhage
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