- High Dose Steroids in Children With Stroke — Recruiting • Phase III • Cardiology / Cardiovascular • NCT04873583.
- This clinical trial deals with focal cerebral arteriopathy and childhood stroke, a rare but devastating condition. Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall disease provoked by infection and there is increasing evidence that inflammatory processes play a crucial role in….
- Sponsor: Insel Gruppe AG, University Hospital Bern.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
This clinical trial deals with focal cerebral arteriopathy and childhood stroke, a rare but devastating condition. Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall disease provoked by infection and there is increasing evidence that inflammatory processes play a crucial role in childhood stroke, influencing the outcome of the disease. Analysis of existing data suggests that outcomes are improved and that there is less stroke recurrence in children treated with steroids to reduce the acute inflammatory processes. This clinical trial will be conducted in over 20 hospitals in several countries…
- : 1. Informed consent of the legal representative of the trial participant documented by signature 2. Age > 6 months & < 18 years at time of stroke 3. Randomisation possible within 48 hours of diagnosis and maximum 96 hours after stroke onset 4. Unilateral arteriopathy according to the following criteria: * Newly acquired neurologic deficits * Specific neuroimaging (MRA) features of either * unilateral stenosis, or * unilateral vessel irregularities within the Central Nervous System (CNS) 5. Unless otherwise defined in the national addendum: Female participants age ≥ 13: Negative pregnancy test (blood or urine)
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.