Cerebral Hemorrhage
Conditions
Keywords
Intraventricular hemorrhage, Subarachnoid hemorrhage, Intracerebral hemorrhage, Pharmacokinetics, Recombinant Proteins, Anticoagulants, Tissue Plasminogen Activator, Pharmacology, Catheters, Indwelling, Cerebral Ventricles
Brief 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.
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. Completion date provided represents the completion date of the grant per OOPD records
Interventions
Sponsors
Study design
Eligibility
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
Countries
United States