Clinical Trials

Study Name: Cardiac Arrest Recovery EEG Study (CARES)
Principal Investigator: Romergryko Geocadin, MD
Johns Hopkins Site PI: R Geocadin (JHH); Matthew Koenig (Johns Hopkins Bayview)
Coordinating Center: Johns Hopkins University School of Medicine
Research Plan: This phase II-B seeks to validate a novel qEEG algorithm using a simplified 2-channel acquisition system for neuromonitoring and prognostication in cardiac arrest survivors. Standard EEG, qEEG, and neurologic evaluation will be performed at 0-4 hours after successful CPR and at scheduled times during the first week of admission. If the patient is treated with hypothermia, continuous EEG will be undertaken during this period. The outcome will be assessed using Cerebral Performance Categories, mRS, Barthel, and a battery of neuropsychological testing at 3 and 6 months.
Target Enrollment: 100
Number of Study Sites: 4
Start Date: November 2007
Anticipated Stop Date: November 2009
Funding Source: NIH R44HL070129
NCT Number: NCT00483873

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: Minimally Invasive Surgery plus tPA for Intracerebral Hemorrhage Evacuation (MISTIE)
Principal Investigators: Daniel Hanley, Mario Zuccarello
Johns Hopkins Site PI: Judy Huang, MD
Coordinating Center: The Johns Hopkins University
Research Plan: The extent of brain injury mediated by intracerebral hemorrhage (ICH) relates directly to the volume of blood and duration of blood exposure to brain tissue. We propose to study stereotactic drain placement and tPA infusion to remove blood from patients with ICH. MISTIE was designed to study the safety, efficacy, and pharmacokinetic properties of ICH dissolution using multiple dosing tiers of tPA. This study will provide the first test of the relationship between minimally invasive clot removal and outcome after ICH.
Target Enrollment: 120
Number of Study Sites: 25
Start Date: Open to enrollment
Anticipated Stop Date: 2011
Funding Source: NINDS

Study Name: Treatment of Subarachnoid Hemorrhage with Human Albumin (ALISAH)
Principal Investigator: José Suarez
Johns Hopkins Site PI: Judy Huang, MD
Coordinating Center: Baylor College of Medicine
Research Plan: This is an open-label, non-randomized, dose-finding study to determine the safety and treatment effect of 4 different dosages of 25% human albumin in patients with aneurysmal subarachnoid hemorrhage. The 4 dosage tiers (per day for 7 days) are: 0.625 g/kg, 1.225 g/kg, 1.85 g/kg, and 2.5 g/kg.
Target Enrollment: 80
Number of Study Sites: 6
Start Date: February 2006
Anticipated Stop Date: February 2010
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 pla tforms 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

Study Name: ESPRIT – Evoked Potential Monitoring of Acute Intracranial Mass lesion
Principal Investigators: Romergryko Geocadin, Matthew Koenig
Sites: The Johns Hopkins Hospital and The Johns Hopkins Bayview Medical Center
Research Plan: ESPRIT is a phase 2 study to develop an automated, evoked potential based indicator of acute neurologic deterioration from intracranial mass lesion.
Target Enrollment: 40
Anticipated Stop Date: 2009
Funding Source: NIH NHLBI - R44 SBIR with Infinite Biomedical Technology

Study Name: qEP Analysis of Comatose Patients: Mutual Synchronicity
Principal Investigators: Romergryko Geocadin/ Matthew Koenig
Sites: The Johns Hopkins Hospital and TheJohns Hopkins Bayview Medical Center
Research Plan: The COMA study looks to use a novel analysis method to show a more meaningful and simplified method of interpreting evoked potentials in patients who are comatose after 6 hours post cardiac arrest. We perform SEP’s within 48 hrs of arrest and then the next day (day 3), day 7 and day 14 or day of discharge whichever comes first.
Target Enrollment: 21
Anticipated Stop Date: 2008
Funding Source: NIH NHLBI - R44 SBIR with Infinite Biomedical Technology

Study Name: Study of Heart Rate Variability in the Neurocritical Care Environment
Principal Investigators: Romergryko Geocadin/Hans Adrian Puttgen
Coordinating Center: The Johns Hopkins Hospital
Research Plan: This is an ongoing prospective study of the changes in heart rate variability/ autonomic function in patients with acute mass lesions in the neurocritical care environment. The study seeks to develop a novel HRV monitoring algorithm to detect critical changes in autonomic function associated with acute brain injury.
Target Enrollment: 20
Number of Study Sites: 1
Start Date: June 2008
Anticipated Stop Date: June 200 2009
Funding Source: Internal funding – NIH-R43/SBIR grant submitted

Study Name: Bolus 23.4% Saline for Treating Elevated Intracranial Pressure: A Prospective Assessment
Principal Investigators: Alexander Papangelou, Marek Mirski
Sites: The Johns Hopkins Hospital and The Johns Hopkins Bayview Medical Center
Research Plan: This is a prospective observational study to evaluate the effect of administering 23.4% saline to patients with elevated ICP (greater than 20) and to those who are decompensating clinically due to herniation. We will be following physiologic parameters as well as laboratory values to understand the duration of effect and the physiologic alterations that occur due to administration of this therapy. Our hopes are by understanding the natural history of 23.4%, we can maximize the effect of hyperosmolar therapy in dyer clinical situations.
Target Enrollment: 30
Anticipated Stop Date: 2009
Funding Source: Johns Hopkins NeuroCritical Care Division