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HU Prevent is a clinical study that aims to compare the drug hydroxyurea to a placebo in children with sickle cell disease. The goal of this clinical trial is to determine if hydroxyurea can prevent brain injury. Some of the most devastating complications of sickle cell disease, including stroke, silent stroke, and fast blood flow to the brain, can occur early in a child’s life. Through information gained from the HU Prevent Study, we hope to help prevent these common problems in children with sickle cell disease.
Without treatment, 1 in 10 children with sickle cell disease will have a stroke by age 18 and another 1 in 3 will have a silent stroke. Strokes and silent strokes often reduce intelligence and can lead to difficulty with school work. About 1 in 10 children with sickle cell disease have blood flow to the brain that is too fast and need regular transfusions to prevent a stroke.
Around 25 hospitals across the country are participating in this study in an effort to improve the lives of children and families living with sickle cell disease. Johns Hopkins BIOS is serving as the national coordinating center.
PubFacts Trial Details:
Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
POINT is a randomized, double-blind, multicenter clinical trial to determine whether clopidogrel (Plavix®) is effective in preventing major ischemic vascular events such as ischemic stroke and myocardial infarction in newly-diagnosed patients with TIA and minor ischemic stroke. Study participants are enrolled within 12 hours of their symptom onset and presentation to the emergency department and are then followed for 90 days after randomization.
Johns Hopkins is participating along with up to 350 other investigational sites in partnership with the National Institute of Neurological Disorders and Stroke (NINDS) and the NETT Network. The study. which started in 2010, will enroll 5840 participants over approximately 7 years.
Johns Hopkins' Principal Investigator
Victor Urrutia, MD
DIAS-4 Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke
DIAS-4 is a phase III study, sponsored by Lundbeck to evaluate the efficacy and safety of desmoteplase in study participants with acute ischemic stroke. It is a follow-on to the DIAS-3 study which completed in March-2014. BIOS (Brain Injury Outcomes Clinical Trial Coordinating Center) is acting as a local coordinating team for this study at Johns Hopkins.
Desmoteplase is an investigational recombinant tissue plasminogen activator (rt-PA). Early studies suggest is may have a lower bleeding risk than alteplase when given via intravenous administration in ischemic stroke. It has a broader time window (up to 9 hours) and can be given as a single bolus injection making it easier to use.
The primary outcome measure is the score on the 90-day Modified Rankin Scale. The NIHSS at Day-90 is a secondary outcome measure.
This therapeutic agent was initially discovered in the saliva of a vampire bat.
Research Study of Motor Learning and Acute Recovery Time Course in Stroke
SMARTS is a series of studies conducted by DR. John Krakauer at Johns Hopkins exploring how the brain changes over the first year following a stroke. Dr. Krakauer is using several non-invasive techniques, including MRI, transcranial magnetic stimulation and measures of arm movement in order to learn more about how individuals recover from stroke. It is hoped that this information will help predict recovery and help researchers understand how changes in the brain relate to the performance of movement. This study is being conducted at Johns Hopkins Hospital and the Kennedy Krieger Institute. BIOS (Brain Injury Outcomes Service) is providing trial coordination.
The pilot study, SMARTS-1, was conducted to evaluate and quantify the biologic factors that are associated with the natural history of recovery over stroke, and to investigate the relationship between motor learning capacity and functional recovery over the course of 12 months post stroke.
In order to learn about recovery from stroke, noninvasive techniques including MRI, transcranial magnetic stimulation, cognitive testing, and a variety of methods of measurement of the ability to move arms was tested at 5 time-points over a year following stroke.
This study was an observational study, conducted for the past 2 years, enrolling participants within 4-6 weeks following an acute stroke.
The Hopkins researchers had considerable success with the 16 patients enrolled—10 have completed the year of testing thus far. This was a multi-center study, with additional patients enrolled at Columbia University, and in Zurich Switzerland.
SMARTS 2 will open for recruitment this summer. The premise of the new trial is that during the early period, when most of a patient's spontaneous motor recovery occurs, training will have the greatest effects.
Brain Injury Outcomes (BIOS) Clinical Trial Coordinating Center is involved in dozens of clinical trials, both single-site and multicenter, some of which are sponsored by a pharmaceutical / medical device companies or hospital consortiums (and may not have their own website).
The large international multicenter clinical trials that we directly sponsor are listed below. This area of our website is intended primarily for our investigational sites, but anyone interested in BIOS or our clinical trials is welcome.
Please keep in mind that the drugs and/or devices you read about here may still be investigational and only for use by appropriately-trained physicians and surgeons participating in these clinical trials.
MISTIE II is a multicenter international clinical program to determine if giving a thrombolytic agent through a small catheter (a minimally-invasive surgical approach called MIS+TPA) might be better than standard medical care for treating a type of bleeding in the brain called intracerebral hemorrhage or ICH.
The MISTIE II trial enrolled its fiftieth and final patient in August-2011.Enrollment is now closed as we anxiously wait for the last patient to complete the one-year follow-up. Preliminary data analyses indicate this approach can be used safety to rapidly remove the damaging blood clot from the brain.
MISTIE-ICES is a sub-study co-sponsored with a team of surgeons at UCLA where an image-guided endoscope is used instead of the catheter and thrombolytic agent. An endoscope allows the surgeon to visualize the clot and immediately remove the blood. This approach is more invasive, but it removes the blood faster. ICES is a phase-II trial, currently with about 20 patients. The last patient enrolled in April-2012 and is in the one-year follow-up period. Final results from this trial are expected by mid-2013.
Meanwhile, a grant application for MISTIE-III has been submitted to the National Institute of Neurological Disorders and Stroke (NINDS). This new trial, if approved for funding in late 2012, will evaluate this minimally-invasive surgery plus thrombolysis medical approach in 500 additional patients, this time to establish in a large international randomized clinical trial (RCT) whether this ability to remove the blood actually results in better neurologic outcomes for these hemorrhagic stroke patients. We are currently recruiting potential new sites for this trial; interested clinical investigators are welcome to contact us.
Patients with an ICH will sometimes have bleeding from an ICH that extends into the brain's ventricular system. This severe bleeding is called intraventricular hemorrhage or IVH. The CLEAR program is evaluating if a similar MIS+TPA approach will improve the neurologic outcome and survival of patients with IVH. CLEAR-III, an international 500-patient, 5-year phase-III clinical trial, started in September 2009 and is about half-way completed with enrollment. Results from this study are expected in 2014. Most of the 80+ clinical sites are underway, but we are always looking for new clinical investigators that have a strong interest and suitable staff/facility to join the consortium; if interested, please contact us for more information.