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Clinical Trials

Study Name: Simvastatin for Intracerebral Hemorrhage Study.
Principal Investigator: Neeraj Naval, MD.
Research Plan: Prospective double blinded placebo controlled randomized clinical trial analyzing outcomes in patients admitted within 24 hours of spontaneous ICH who will receive either generic simvastatin 80 mg daily or placebo for 14 days (or until death or discharge). Endpoints: Primary: Relative perihematomal edema at 7 and 14 days; Secondary: 30 day mortality, 90 day functional outcomes
Target Enrollment: 90 patients.
Enrollment period: 3 years.
Site: Johns Hopkins Bayview Medical Center
Funding Source: Grant Number UL1 RR 025005 from the National Center for Research Resources, a component of the National Institutes of Health (NIH)

Study Name: Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage-III (CLEAR-IVH III)
Principal Investigators: Daniel Hanley, Issam Awad
Johns Hopkins Site PI: Wendy Ziai, MD
Coordinating Center: The Johns Hopkins University
Research Plan: CLEAR-IVH III is a study of intraventricular tPA for clearance of intraventricular hemorrhage (IVH). Patients with intraventricular hemorrhage (IVH) who have undergone placement of an external ventricular drain (EVD) will be enrolled. Clot size must be stable for at least 6 hours and tPA must be administered within 48 hours of onset. Placebo or 1 mg of tPA is administered via every 8 hours for up to 96 hours (12 doses) or clearance of IVH. The primary endpoint is 6-month modified Rankin scale score. Secondary endpoints include multiple functional outcome assessment scales, mortality, duration of ventricular drainage, and interval to clot resolution.
Target Enrollment: 500
Number of Study Sites: 70
Start Date: Fall 2008
Anticipated Stop Date: 2013
Funding Source: NINDS

Study Name: Silent Stroke and Inflammation in a Population of Patients at Risk for Cerebrovascular Disease
Principal Investigator: Paul Nyquist
Johns Hopkins Site PI: Paul Nyquist
Coordinating Center: Johns Hopkins, "Siblings and Heart"
Research Plan: This is a concurrent cohort study of an ongoing prospective epidemiological study looking at the relationship between genes and small vessel ischemic disease in a population genetically enriched for risk factors for coronary artery disease.
Target Enrollment: 1000
Number of Study Sites: 1
Start Date: Jan 2005
Anticipated Stop Date: Indefinite
Funding Source: GCRC

Study Name: Biomarkers and Subarachnoid Hemorrhage
Principal Investigator: Paul Nyquist
Johns Hopkins Site PI: Paul Nyquist
Coordinating Center: Johns Hopkins
Research Plan: This is an ongoing prospective study of subarachnoid hemorrhage. We are banking serum and CSF. We are examining inflammatory mediators that influence the development of subarachnoid hemorrhage using a variety of proteomic platforms such as SELDI, a variety of protein based chips, as well as mass spect.
Target Enrollment: 300
Number of Study Sites: 1
Start Date: Jan 2005
Anticipated Stop Date: Indefinite
Funding Source: Internal funding

Study Name: Nitric Oxide Metabolism in the Cerebrospinal Fluid of Patient's with Subarachnoid Hemorrhage
Principal Investigator: Paul Nyquist
Johns Hopkins Site PI: Paul Nyquist
Coordinating Center: Johns Hopkins
Research Plan: This is an ongoing prospective study of patients with Subarachnoid Hemorrhage; we are analyzing CSF for the metabolites of nitric oxide metabolism as a pilot study to look at differences in the concentration of these metabolites in relation to different out comes such as vasospasm.
Target Enrollment: 500
Number of Study Sites: 1
Start Date: Jan 2006
Anticipated Stop Date: Indefinite
Funding Source: Internal funding

 

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