Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Baltimore, Maryland 21287


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.


Study summary:

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. Completion date provided represents the completion date of the grant per OOPD records


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


NCT ID:

NCT00029315


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21287
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.