High Dose Steroids in Children With Stroke

A vizsgálat adatai

Ki végzi

Insel Gruppe AG, University Hospital Bern

Azonosító

NCT04873583EU 2022-500631-36-00

A regiszteradat frissítve

2025. november 18.

Eredeti leírás

This clinical trial deals with focal cerebral arteriopathy and childhood stroke, a rare but devastating condition.A teljes eredeti leírásKevesebb

High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) Trial

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 in order to investigate this.

Participants will be randomly separated into two groups. The first group will be treated with standard of care (including aspirin) combined with high dose steroids. The second group will be treated with standard of care (including aspirin) but without steroid treatment.

The objective is to investigate if children treated with a combination of high dose steroid and aspirin will have a better and quicker recovery of FCA, better clinical functional outcome, and less recurrence compared to children treated with aspirin alone.

This project has been identified by international pediatric stroke experts as the most important topic for a clinical trial in the field and is as well one of the most important research priorities identified by parents. The study results will also provide insight into the evolution of inflammatory vessel disease.

Bevonási feltételek: Informed consent of the legal representative of the trial participant documented by signature; Age > 6 months \& < 18 years at time of stroke; Randomisation possible within 48 hours of diagnosis and maximum 96 hours after stroke onset; 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); Unless otherwise defined in the national addendum: Female participants age ≥ 13: Negative pregnancy test (blood or urine).

Kizáró feltételek: Previous stroke; Contraindication to steroid treatment as e.g. a congenital or acquired immunodeficiency; Known syndromal disorders, as e.g. Trisomy 21, Neurofibromatosis type 1; Known genetic vasculopathies as e.g. posterior fossa anomalies, hemangioma, arterial anomalies, cardiac anomalies and eye anomalies syndrome (PHACES), actin alpha 2 (ACTA II); Moyamoya or sickle cell disease; Evidence of underlying systemic disorders, as e.g. lupus, rheumatoid problems; Secondary CNS angiitis due to infections (meningitis, endocarditis, borreliosis), or generalised angiitis due to rheumatic or other autoimmune problems; On steroid treatment at disease onset; Participation in another interventional study within the 30 days preceding the indication stroke and during the present study; Small vessel cerebral vasculitis (primary CNS vasculitis); Bilateral arteriopathy; Arterial dissection(s); Progressive large to medium childhood primary angiitis of the CNS (cPACNS ) with 2 of the following 3 criteria:; pre-existing progressive neurocognitive dysfunction; bilateral MRI lesions/vessel involvement; small vessel arterial stenosis; Inability to follow the procedures of the study, e.g. due to language problems.

ClinicalTrials.gov NCT04873583 · EU CTIS 2022-500631-36-00