High dose steroids for children with stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of high dose steroids in children suffering from arterial ischemic stroke, particularly focusing on those with focal cerebral arteriopathy (FCA). Participants will be randomly assigned to receive either standard care with high dose steroids or standard care alone. The study aims to determine if the addition of steroids can improve outcomes and reduce the recurrence of strokes in this vulnerable population. Conducted across over 20 hospitals in multiple countries, this trial seeks to provide high-level evidence for the treatment of childhood stroke related to FCA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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)

Exclusion Criteria:

1. Previous stroke
2. Known syndromal disorders, as e.g. Trisomy 21, Neurofibromatosis type 1
3. Known genetic vasculopathies as e.g. posterior fossa anomalies, hemangioma, arterial anomalies, cardiac anomalies and eye anomalies syndrome (PHACES), actin alpha 2 (ACTA II)
4. Moyamoya or sickle cell disease
5. Small vessel cerebral vasculitis (primary CNS vasculitis)
6. Bilateral arteriopathy
7. Arterial dissection(s)
8. Evidence of underlying systemic disorders, as e.g. lupus, rheumatoid problems
9. Secondary CNS angiitis due to infections (meningitis, endocarditis, borreliosis), or generalised angiitis due to rheumatic or other autoimmune problems
10. Progressive large to medium childhood primary angiitis of the CNS (cPACNS ) with 2 of the following 3 criteria:

    1. pre-existing progressive neurocognitive dysfunction
    2. bilateral MRI lesions/vessel involvement
    3. small vessel arterial stenosis
11. On steroid treatment at disease onset
12. Contraindication to steroid treatment as e.g. a congenital or acquired immunodeficiency
13. Inability to follow the procedures of the study, e.g. due to language problems
14. Participation in another interventional study within the 30 days preceding the indication stroke and during the present study

Where it's running

• Sydney Childrens Hospital Randwick
  Randwick, New South Wales, Australia Recruiting
• Sydney Childrens Hospital Network
  Westmead, New South Wales, Australia Recruiting
• Melbourne Childrens Hospital
  Melbourne, Victoria, Australia Recruiting
• Universitätsklinik für Kinder und Jugendheilkunde Wien
  Vienna, Austria Recruiting
• Department of Pediatric and Adolescence Medicine Copenhagen University Hospital
  Copenhagen, Denmark Recruiting
• L'ASSISTANCE PUBLIQUE-HOPITAUX DE MARSEILLE (AP-HM) - Hôpital de la Timone
  Marseille, Aix-en-Provence, France Recruiting

Study contacts

• Study coordinator: Maja Steinlin, Dr. med.
• Email: maja.steinlin@insel.ch
• Phone: +41 31 6329424

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.