Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage - Tabular View

Tracking Information
First Received Date ^ICMJE	January 10, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	September 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00029315 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage
Official Title ^ICMJE	Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Pharmacokinetics/Dynamics Study
Condition ^ICMJE	Cerebral Hemorrhage
Intervention ^ICMJE	Drug: Recombinant Tissue Plasminogen Activator (rt-PA)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Enrollment ^ICMJE	30
Completion Date	September 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00029315
Responsible Party
Study ID Numbers ^ICMJE	FD-R-2018-01, FD-R-002018-01
Study Sponsor ^ICMJE	FDA Office of Orphan Products Development
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	FDA Office of Orphan Products Development
Verification Date	December 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP