Stroke in Childhood Due to Inflammatory Vessel Narrowing Treatment with Steroids
Descrizione riassuntiva dello studio
We want to investigate in the case of stroke triggered by a vessel narrowing whether cortisone (steroids) is effective and well-tolerated. The medication contains the active ingredient steroids/cortisone and has the following properties: steroids are an anti-inflammatory hormone and have been used for this purpose in medicine for many decades. In this study, we aim to achieve a faster reduction of the inflammatory swelling of the vessel wall. Steroids are increasingly used in pediatric stroke in cases of inflammatory vessel narrowing, without it ever being proven that this helps the child. Objective and Method: The aim is to show whether in children with a stroke provoked by inflammatory vessel narrowing, the additional therapy with steroids (cortisone) as anti-inflammatory medications really brings benefits or not. In this study, which will be conducted at various international centers, a baseline therapy with aspirin will be compared against aspirin as well as high doses of steroids in two parallel groups. Each arm will include 35 children aged 6 months to 18 years, in whom an acute stroke due to inflammatory vessel narrowing could be demonstrated. Allocation to the two groups will be done randomly. Children with another form of vascular disease or a problem that does not allow steroid administration will be excluded. The respective therapy begins at most 96 hours after the first symptoms. A clinical follow-up will occur at 1, 3, 6, and 12 months and an MRI after 1, 3, and 6 months. Importance: In pediatric stroke, evidence-based treatment recommendations are largely lacking. Through this study, we will achieve good evidence in an important area of pediatric stroke for acute therapy.
(BASEC)
Intervento studiato
Experimental Intervention:
In addition to standard therapy, 3 days of methylprednisolone 30 mg/kg body weight (max. 1000 mg/dose) followed by 4 weeks of tapering with prednisolone tablets
Control Group:
Standard therapy (aspirin 5 mg/kg body weight as well as supportive therapy with blood pressure and temperature monitoring (if necessary), treatment of any epileptic seizures, neurosurgical decompression in case of significant swelling of the infarct area, rehabilitation)
(BASEC)
Malattie studiate
Ischemic Stroke in Childhood Triggered by Inflammatory Narrowing of a Cerebral Artery
(BASEC)
Children aged 6 months to 18 years Acute ischemic stroke (reduced blood flow) triggered by inflammatory narrowing of the vessels. Treatment start possible within a maximum of 96 hours after symptom onset (BASEC)
Criteri di esclusione
Secondary vascular inflammation due to infections, rheumatic problems, etc. Children with Moyamoya or sickle cell anemia Vascular wall injury (dissection) Already existing steroid therapy or contraindication to steroids (BASEC)
Luogo dello studio
Basilea, Bellinzona, Berna, Chur, Ginevra, Losanna, Luzern, Sion, San Gallo, Zurigo
(BASEC)
Sponsor
Lumis International GmbH, Giesebrechtstrasse 15, 10629 Berlin, Germany
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Maja Steinlin
0041 31 632 94 24
maja.steinlin@clutterinsel.chDivision of Pediatric Neurology, Development and Rehabilitation, Inselspital, Children’s Universi-ty Hospital, CH-3010 Bern
(BASEC)
Informazioni generali
Bern university hospital, Inselspital Bern, Kinderklinik,
+41 31 6329424
maja.steinlin@clutterinsel.ch(ICTRP)
Informazioni generali
Bern university hospital, Inselspital Bern, Kinderklinik
+41 31 6329424
maja.steinlin@clutterinsel.ch(ICTRP)
Informazioni scientifiche
Bern university hospital, Inselspital Bern, Kinderklinik,
+41 31 6329424
maja.steinlin@clutterinsel.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
02.11.2021
(BASEC)
ID di studio ICTRP
NCT04873583 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
High Dose Steroids in Children with Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) trial (BASEC)
Titolo accademico
High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) Trial (ICTRP)
Titolo pubblico
High Dose Steroids in Children With Stroke (ICTRP)
Malattie studiate
Paediatric Stroke (ICTRP)
Intervento studiato
Drug: MethylprednisoloneDrug: Prednisolone (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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 (ICTRP)
non disponibile
Endpoint primari e secondari
Change in Focal Cerebral Arteriopathy Severity Score (FCASS) from baseline (ICTRP)
Functional impairment outcome measured by Pediatric Stroke Outcome Measure (PSOM);Recovery assessed by Recovery and Recurrence Questionnaire (RRQ);Degree of disability or dependence by modified Rankin Scale (mRS);Clinical outcome by Vineland adaptive behavior scale (VABS);Change in FCASS (Focal Cerebral Arteriopathy Severity Score) from baseline;Volume of stroke;Residual vasculopathy;Stroke recurrence after index stroke;Stroke recurrence after index stroke in relation to the initial degree of vessel stenosis;Stroke Quality of Life Measure (PSQLM);Preschool Wechsler Intelligence Scale for Children (WISC V) / Wechsler Preschool and Primary Scale of Intelligence (WIPPSI IV);Delis-Kaplan Executive Function System (D-KEFS);Continuous performance task (CPT-III) (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
University of Bern;LUMIS International GmbH (ICTRP)
Contatti aggiuntivi
Maja Steinlin, Dr. med.;Maja Steinlin, Dr. med., maja.steinlin@insel.ch, +41 31 6329424, Bern university hospital, Inselspital Bern, Kinderklinik, (ICTRP)
ID secondari
2022-500631-36-00, 2021-005571-39, 2021-00453, 305395, HREC/78937/RCHM-2022, 1473_PASTA (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT04873583 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile