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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04873583
Registration number
NCT04873583
Ethics application status
Date submitted
15/04/2021
Date registered
5/05/2021
Date last updated
9/01/2024
Titles & IDs
Public title
High Dose Steroids in Children With Stroke
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Scientific title
High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) Trial
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Secondary ID [1]
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2021-005571-39
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Secondary ID [2]
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1473_PASTA
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Universal Trial Number (UTN)
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Trial acronym
PASTA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Paediatric Stroke
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Condition category
Condition code
Stroke
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Haemorrhagic
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Stroke
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Methylprednisolone
Treatment: Drugs - Prednisolone
Experimental: Steroids + Standard of care - Standard of care (including aspirin) and intravenous steroids, followed by oral tapering.
No Intervention: Standard of care - Standard of care (including aspirin)
Treatment: Drugs: Methylprednisolone
At the time of inclusion, intravenous Methylprednisolone for 3 days. Dose: 30 mg/kg/day (max. 1000 mg/dose)
Treatment: Drugs: Prednisolone
Intravenous treatment will be immediately followed by oral tapering with Prednisolone.
Oral Prednisolone, 2 weeks (week 1 and 2) Dose: 1 mg/kg/day (max 40 mg/day) Oral Prednisolone, 2 weeks (week 3 and 4) Dose: 0.5 mg/kg/day (max 20 mg/day)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Focal Cerebral Arteriopathy Severity Score (FCASS) from baseline
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Assessment method [1]
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The FCASS is a scaling system that has been developed to improve diagnostic criteria and to better document the typical course of initial worsening followed by improvement in FCA-i (focal cerebral arteriopathy of inflammatory type).
FCASS Minimum score (best outcome): 0 FCASS Maximum baseline score (worst outcome): 20 FCASS Maximum follow up score (worst outcome): 21
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Timepoint [1]
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1 month (30 days)
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Secondary outcome [1]
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Functional impairment outcome measured by Pediatric Stroke Outcome Measure (PSOM)
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Assessment method [1]
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The PSOM is a measure that has been specifically developed and validated for pediatric stroke patients and addresses pediatric specific domains such as development, behavior and cognition in addition to sensory-motor and language function.
PSOM Minimum score (best outcome): 0 PSOM Maximum baseline score (worst outcome): 10
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Timepoint [1]
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1, 3, 6 and 12 months
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Secondary outcome [2]
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Recovery assessed by Recovery and Recurrence Questionnaire (RRQ)
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Assessment method [2]
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The Pediatric Recovery and Recurrence Questionnaire was specifically developed and validated for pediatric stroke patients and addresses pediatric- specific problems of manifestation of stroke and difficulties in reliable clinical examination.
Minimum score (best outcome): 0 Maximum baseline score (worst outcome): 10
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Timepoint [2]
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1, 3, 6, and 12 months
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Secondary outcome [3]
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Degree of disability or dependence by modified Rankin Scale (mRS)
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Assessment method [3]
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Minimum score (best outcome): 0 Maximum baseline score (worst outcome): 6
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Timepoint [3]
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1, 3, 6, and 12 months
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Secondary outcome [4]
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Clinical outcome by Vineland adaptive behavior scale (VABS)
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Assessment method [4]
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The vineland adaptive behavior scale is a validated instrument to monitor cognitive and behavior problems of children by interview.
(range=40-160, the higher the score the better the performance)
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Timepoint [4]
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6 and 12 months
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Secondary outcome [5]
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Change in FCASS (Focal Cerebral Arteriopathy Severity Score) from baseline
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Assessment method [5]
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The FCASS is a scaling system that has been developed to improve diagnostic criteria and to better document the typical course of initial worsening followed by improvement in FCA-i (focal cerebral arteriopathy of inflammatory type).
FCASS Minimum score (best outcome): 0 FCASS Maximum baseline score (worst outcome): 20 FCASS Maximum follow up score (worst outcome): 21
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Timepoint [5]
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6 months
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Secondary outcome [6]
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Volume of stroke
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Assessment method [6]
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Volume of stroke will be measured by modASPECTS in diffusion-weighted MRI (DWI) and fluid-attenuated inversion recovery (FLAIR) images.
Higher scores represent greater volumes, with a range of 0-30 (15 per hemisphere).
modASPECTS: Modified pediatric ASPECTS
ASPECTS: Alberta stroke program early CT score
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Timepoint [6]
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baseline, 1, 3 (if imaging is available) and 6 months
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Secondary outcome [7]
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Residual vasculopathy
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Assessment method [7]
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Residual vasculopathy measured by FCASS (Focal Cerebral Arteriopathy Severity Score)
The FCASS is a scaling system that has been developed to improve diagnostic criteria and to better document the typical course of initial worsening followed by improvement in FCA-i (focal cerebral arteriopathy of inflammatory type).
FCASS Minimum score (best outcome): 0 FCASS Maximum baseline score (worst outcome): 20 FCASS Maximum follow up score (worst outcome): 21
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Timepoint [7]
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6 months
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Secondary outcome [8]
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Stroke recurrence after index stroke
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Assessment method [8]
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Stroke recurrence is defined as
(i) new focal neurological deficit(s)
(ii) worsening of the neurological deficits by > 4 pedNIHSS points lasting for more than 24 hours with new or increased diffusion restriction at the time of recurrence (with or without FLAIR/T2 lesions) in the corresponding vascular territory, or
(iii) new areas of clinically silent infarction, remote from the initial infarct (at 1 and 6 months)
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Timepoint [8]
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1, 6 and 12 months
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Secondary outcome [9]
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Stroke recurrence after index stroke in relation to the initial degree of vessel stenosis
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Assessment method [9]
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Degree of vessel stenosis measured by change in FCASS from baseline to follow-up.
Stroke recurrence will be measured as proportion in each category of vessel stenosis.
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Timepoint [9]
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6 and 12 months
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Secondary outcome [10]
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Stroke Quality of Life Measure (PSQLM)
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Assessment method [10]
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For children between 2 -18 years quality of life will be assessed with the Pediatric Stroke Quality of Life Measure (PSQLM) (range=-10 to 10, the higher the score the better the performance)
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Timepoint [10]
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12 month
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Secondary outcome [11]
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Preschool Wechsler Intelligence Scale for Children (WISC V) / Wechsler Preschool and Primary Scale of Intelligence (WIPPSI IV)
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Assessment method [11]
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For Children between 2 -18 years intelligence will be assessed by Preschool Wechsler Intelligence Scale for Children (WISC V) / Wechsler Preschool and Primary Scale of Intelligence (WIPPSI IV, as age appropriate) (range=40-160, the higher the score the better the performance)
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Timepoint [11]
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12 month
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Secondary outcome [12]
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Delis-Kaplan Executive Function System (D-KEFS)
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Assessment method [12]
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Children > 8 years will undergo specific evaluation of executive function (EF). They will be assessed with the Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test, Delis-Kaplan Executive Function System (D-KEFS) Color-Word-Interference Test (range=1-19, the higher the score the better the performance)
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Timepoint [12]
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12 month
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Secondary outcome [13]
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Continuous performance task (CPT-III)
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Assessment method [13]
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Children > 8 years will undergo specific evaluation of attention. They will be assessed with the Continuous performance task (CPT-III). (range=20-80, the higher the score the better the performance)
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Timepoint [13]
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12 month
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Eligibility
Key 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)
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Minimum age
6
Months
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/11/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2026
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Actual
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Sample size
Target
70
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Sydney Childrens Hospital Randwick - Randwick
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Recruitment hospital [2]
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Sydney Childrens Hospital Network - Westmead
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Recruitment hospital [3]
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Queensland Childrens Hospital - South Brisbane
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Recruitment hospital [4]
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Melbourne Childrens Hospital - Melbourne
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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3052 - Melbourne
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Wien
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Country [2]
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France
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State/province [2]
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Alsace
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Country [3]
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France
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State/province [3]
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Auvergne-Rhône-Alpes
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Country [4]
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France
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State/province [4]
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Ile De France
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Country [5]
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France
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State/province [5]
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Provence-Alpes-Côte d'Azur
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Country [6]
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France
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State/province [6]
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Lille
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Country [7]
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Germany
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State/province [7]
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Baden-Württemberg
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Country [8]
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Germany
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State/province [8]
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Baden-Wüttemberg
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Country [9]
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Germany
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State/province [9]
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Bayern
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Country [10]
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Germany
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State/province [10]
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Nordrhein-Westfahlen
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Country [11]
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Germany
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State/province [11]
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Berlin
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Country [12]
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Switzerland
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State/province [12]
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Graubünden
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Country [13]
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Switzerland
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State/province [13]
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Ticino
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Country [14]
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Switzerland
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State/province [14]
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Valais
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Country [15]
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Switzerland
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State/province [15]
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Vaud
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Country [16]
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Switzerland
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State/province [16]
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Basel
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Country [17]
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Switzerland
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State/province [17]
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Bern
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Country [18]
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Switzerland
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State/province [18]
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Geneva
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Country [19]
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Switzerland
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State/province [19]
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Luzern
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Country [20]
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Switzerland
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State/province [20]
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Saint Gallen
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Country [21]
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Switzerland
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State/province [21]
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Zürich
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Country [22]
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United Kingdom
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State/province [22]
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Cambridgeshire
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Country [23]
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United Kingdom
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State/province [23]
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Hampshire
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Country [24]
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United Kingdom
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State/province [24]
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Lancashire
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Country [25]
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United Kingdom
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State/province [25]
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Tyne And Wear
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Country [26]
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United Kingdom
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State/province [26]
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Bristol
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Funding & Sponsors
Primary sponsor type
Other
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Name
Insel Gruppe AG, University Hospital Bern
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Bern
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04873583
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Trial related presentations / publications
Steinlin M, O'callaghan F, Mackay MT. Planning interventional trials in childhood arterial ischaemic stroke using a Delphi consensus process. Dev Med Child Neurol. 2017 Jul;59(7):713-718. doi: 10.1111/dmcn.13393. Epub 2017 Jan 25.
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Public notes
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Contacts
Principal investigator
Name
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Maja Steinlin, Dr. med.
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Address
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Bern university hospital, Inselspital Bern, Kinderklinik
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Maja Steinlin, Dr. med.
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Address
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Country
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Phone
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+41 31 6329424
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04873583
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