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
Cerebral Hemorrhage	Drug: Recombinant Tissue Plasminogen Activator (rt-PA)	Phase II

Further Study Details: 

Expected Total Enrollment:  30

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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

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

Maryland
      The Johns Hopkins University, Baltimore,  Maryland,  21287,  United States; Recruiting

Study ID Numbers:  FD-R-2018-01; FD-R-002018-01
Record last reviewed:  December 2001
Last Updated:  October 13, 2004
Record first received:  January 10, 2002
ClinicalTrials.gov Identifier:  NCT00029315
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08