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The purpose of this study is to test the safety and effectiveness of a single dose of fingolimod in patients with primary spontaneous intracerebral hemorrhage (ICH).
This is a double-blinded, placebo-controlled pilot trial of fingolimod in patients with primary spontaneous intracerebral hemorrhage. Eligible participants will be allocated to study groups using fixed allocation randomization and a computer-based random number-generating allocation. Participants will be monitored at time of enrollment and days 1, 3 5, 7, and 14 (discharge dependent) by 2 blinded assessors (neuroscience subspecialists) and will receive standard of care for the duration of the study. After discharge from the hospital, participants will enter a follow up phase of 12 months, with clinic visits at 30±14 days, 90±14 days, 180±14 days, and 365±14 days. They will receive a standard of care MRI scan at the 30 day visit and standard of care CT of the brain at the 90 and 365 day visit and will be assessed with the pre-selected outcome assessments established by the NINDS Common Data Elements for Stroke at these time points.
Fingolimod 0.5 mg, Placebo, Standard of care
Wake Forest University Health Sciences
Not yet recruiting
Wake Forest University Health Sciences
Published on BioPortfolio: 2019-09-18T03:27:37-0400
The Chongqing intracerebral hemorrhage study is a multi-center, prospective, observational study led by professor Qi Li from Chongqing Medical University. Professor Peng Xie will be the se...
Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either the experimental group which will keep them at a normal body temperature or the standard of care...
Views for surgery method selection of intracerebral hemorrhage are still controversial. Since the application of neuroendoscopic technique in intraventricular hemorrhage was confirmed eff...
Study Objective: To analyze if statins are effective in ameliorating perihematomal edema evolution thereby reducing mortality and improving functional outcomes following spontaneous intra...
The purpose of the present study is to explore the efficacy of small doses of oral glibenclamide on brain edema after acute primary intracerebral hemorrhage (ICH), and improving the progno...
To systematically assess the discrimination and calibration of the Intracerebral Hemorrhage score for prediction of short-term mortality in intracerebral hemorrhage patients and to study its determina...
Anticoagulation reversal, intensive blood pressure lowering, neurosurgery and access to critical care might all be beneficial in acute intracerebral hemorrhage (ICH). We combined and implemented these...
Intraventricular hemorrhage (IVH) is a verified independent prognostic parameter in patients with intracerebral hemorrhage (ICH). However, the impact of the extent of IVH on clinical outcomes is unest...
To investigate the impact of intensive blood pressure control on progressive intracerebral hemorrhage and outcome in patients with high blood pressure and intracerebral hemorrhage.
Background and Purpose- We investigated factors associated with early and delayed neurological deterioration (END and DND, respectively) after acute spontaneous intracerebral hemorrhage in the main IN...
The minimum acceptable patient care, based on statutes, court decisions, policies, or professional guidelines.
Organization of medical and nursing care according to the degree of illness and care requirements in the hospital. The elements are intensive care, intermediate care, self-care, long-term care, and organized home care.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Hemorrhage within the orbital cavity, posterior to the eyeball.
Intraocular hemorrhage from the vessels of various tissues of the eye.
Radiology is the branch of medicine that studies imaging of the body; X-ray (basic, angiography, barium swallows), ultrasound, MRI, CT and PET. These imaging techniques can be used to diagnose, but also to treat a range of conditions, by allowing visuali...
Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...