The purpose of the Science and Research section is to facilitate collaboration in patient-oriented research and clinical trials related to critical illness in neurological and neurosurgical conditions. In addition, this section seeks to highlight ongoing clinical, basic, and translational research projects that are germane to patients with stroke, status epilepticus, neuromuscular respiratory failure, intracerebral hemorrhage, hydrocephalus, subarachnoid hemorrhage, traumatic brain and spinal cord injury, and other conditions treated by neurointensivists. This section includes a registry of clinical trials that are seeking collaborative centers or patient referrals. In conjunction with the Clinical Trials column of Currents, the NCS quarterly newsletter, this section is designed to raise awareness of ongoing studies and provide a forum for interaction between research institutions. The section includes links to clinical trials and ongoing studies that have been recently highlighted in Currents. Links to recent NCS award winners and upcoming awards and funding opportunities are also included.
Study Name: Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-2)
Principal Investigator: Adnan Qureshi
Coordinating Center: University of Minnesota
Research Plan: ATACH-2 is a proposed five-year international, multi-center, open-labeled, randomized, controlled Phase III trial to determine the efficacy of early, intensive antihypertensive treatment using IV nicardipine for subjects with co-morbid hypertension and spontaneous ICH.
Target Enrollment: 1350
Number of Study Sites: 150 total (100 domestic, 50 international)
Start Date: currently seeking funding
Anticipated Stop Date: 5 years after start date
Funding Source: Pending
Contact Information: qureshi@umn.edu
NCT Number: N/A
Study Name: Cardiac Arrest Recovery EEG Study (CARES)
Principal Investigator: Romergryko Geocadin, MD
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
Contact Information: rgeocad1@jhmi.edu
NCT Number: NCT00483873
Study Name: PROgnosis in PostAnoxic Coma (PROPAC II)
Principal Investigator: Janneke Horn
Coordinating Center: Academical Medical Center, Amsterdam, The Netherlands
Research Plan: Questions have been raised about the predictive validity of neuron-specific enolase (NSE) and somatosensory evoked potentials (SSEP) in cardiac arrest survivors treated with hypothermia. Our objectives are to determine the level of NSE with 100% predictive value for poor outcome in patients treated with hypothermia after CPR and investigate SSEP during and after hypothermia. Outcomes will be documented using the Glasgow Outcome Scale (GOS). Poor outcome will be defined as death, vegetative state, or severe disability (GOS scores 1-3) 6 months after CPR.
Target Enrollment: 300
Number of Study Sites: 10
Start Date: December 2007
Anticipated Stop Date: December 2010
Funding Source: Dutch Heart Foundation
Contact Information: j.horn@amc.uva.nl
NCT Number: N/A
Study Name: STatus Epilepticus in Resuscitation (STER)
Principal Investigator: Janneke Horn
Coordinating Center: Academical Medical Center, Amsterdam, The Netherlands
Research Plan: In 9-20% of patients who remain in coma after CPR, status epilepticus (SE) is found on EEG. The optimal treatment of a SE in these patients is unknown. This prospective cohort study will determine whether protocolized treatment of SE in cardiac arrest survivors improves neurological outcome. Included patients will be treated with pentobarbital coma, titrated to burst-suppression for at least 24 hours. Subsequent treatment will include valproic acid, phenytoin, and clonazepam. Outcome will be assessed with the GOS at 30 days and 6 months after CPR.
Target Enrollment: 70
Number of Study Sites: 10
Start Date: September 2008
Anticipated Stop Date: December 2010
Funding Source: Pending
Contact Information: j.horn@amc.uva.nl
NCT Number: N/A
Study Name: Erythropoietin Therapy for Subarachnoid Hemorrhage
Principal Investigator: PJ Kirkpatrick, M-Y Tseng
Coordinating Center: University of Cambridge
Research Plan: Vasospasm and impaired autoregulation after subarachnoid hemorrhage (SAH) can be conveniently measured by transcranial Doppler (TCD) and the transient hyperaemic response test (THRT). In this study, we will explore the effects of erythropoietin (EPO) on vasospasm, autoregulation, and outcome following SAH. Patients will receive 3 doses of either intravenous epoetin beta or placebo in the first week as part of a randomised, double-blind, placebo-controlled trial. Daily TCD assessments for vasospasm and abnormal autoregulation will be undertaken.
Target Enrollment: 80
Number of Study Sites: 1
Start Date: May 2005
Anticipated Stop Date: April 2007
Funding Source: Roche Foundation for Anemia Research, Roche Products (UK)
Contact Information: pjk21@medschl.cam.ac.uk, myt22@cam.ac.uk
NCT Number: 00140010
Study Name: Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage-III (CLEAR-IVH III)
Principal Investigator: Daniel Hanley, Issam Awad
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
Contact Information: klane@jhmi.edu
NCT Number: N/A
Study Name: Minimally Invasive Surgery plus tPA for Intracerebral Hemorrhage Evacuation (MISTIE)
Principal Investigator: Daniel Hanley, Mario Zuccarello
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
Contact Information: klane@jhmi.edu
NCT Number: 00224770
Study Name: Gene Discovery for Intracerebral Hemorrhage
Principal Investigator: Jonathan Rosand
Coordinating Center: Massachusetts General Hospital
Research Plan: Case control genome-wide association study of 1000 patients with intracerebral hemorrhage (ICH) not taking warfarin, 1000 controls not taking warfarin, 600 patients with warfarin-related ICH, and 1200 controls taking warfarin. We aim to identify genetic variants associated with warfarin-related ICH and warfarin dose requirements. We will also identify common sequence variation in non-warfarin case and control samples.
Target Enrollment: 1600 cases, 2200 controls
Number of Study Sites: 14
Start Date: June 2008
Anticipated Stop Date: June 2013
Funding Source: NINDS
Contact Information: jrosand@partners.org
NCT Number: N/A
Principal Investigator: Claudia Robertson
Coordinating Center: Baylor College of Medicine
Research Plan: The primary objective of this randomized, placebo-controlled study is to determine the effect of early administration of recombinant human Epo (rhEpo) on long-term neurological outcome in patients with severe TBI. We will examine the effects of rhEpo on hemoglobin concentration, brain oxygenation, the need for blood transfusion, and systemic complications. This study consists of 2 parts: 1) a treatment phase, and 2) a monitoring phase. In the treatment phase, participants will be randomly assigned a low or high dose rhEpo treatment group or placebo. The monitoring part of the study will then last for up to 6 months after TBI.
Target Enrollment: 200
Number of Study Sites: 2
Start Date: May 2006
Anticipated Stop Date: May 2011
Funding Source: NINDS
Contact Information: claudiar@bcm.tmc.edu
NCT Number: 00313716
Study Name: Treatment of Subarachnoid Hemorrhage with Human Albumin (ALISAH)
Principal Investigator: José Suarez
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
Contact Information: jisuarez@bcm.tmc.edu
NCT Number: 00283400
Study Name: NeuroThera® Effectiveness and Safety Trial - 2 (NEST-2)
Principal Investigator: Justin Zivin
Research Plan: This study is a prospective, double-blind, randomized, sham-controlled, parallel group, multi-center study to assess the safety and effectiveness of the treatment of acute ischemic stroke with the NeuroThera® Laser System within 24 hours of onset. Subjects will be followed for 90 days after stroke onset. The primary effectiveness endpoint will be 90-day modified Rankin Scale (mRS) score of 0-2. The secondary endpoint will be change in NIHSS score from baseline to 90 days, analyzed across the full range of NIHSS scores.
Target Enrollment: 660
Number of Study Sites: 58
Start Date: December 2006
Anticipated Stop Date: December 2008
Funding Source: PhotoThera, Inc
Contact Information: silic@photothera.com
NCT Number: 00419705
Study Name: Spreading Depressions as Secondary Insults after Traumatic Injury to the Human Brain
Principal Investigator: Jed Hartings
Coordinating Center: University of Cincinnati
Research Plan: Spreading mass tissue depolarizations (spreading depression and its variants) cause expansion of ischemic brain lesions and occur in >50% of severe brain trauma patients. This prospective, observational study will test the null hypothesis that spreading depolarizations have no impact on 6 month neurologic outcome (GOS-E) after traumatic brain injury. Neurosurgical trauma patients will be monitored for depolarizations by continuous electrocorticography. Secondary objectives are to identify pathologic and metabolic (PtiO2) risk factors associated with spreading depression and its variants.
Target Enrollment: 180
Number of Study Sites: 5
Start Date: October 1, 2008
Anticipated Stop Date: April 1, 2012
Funding Source: Department of Defense
Contact Information: jed.hartings@uc.edu
NCT Number: N/A
Neurocritical Care Journal
Clinical Trials in Neurocritical Care
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