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High Dose Steroids in Children With Stroke (PASTA)

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ClinicalTrials.gov Identifier: NCT04873583
Recruitment Status : Recruiting
First Posted : May 5, 2021
Last Update Posted : May 3, 2023
Sponsor:
Collaborator:
University of Bern
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Study Description
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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.


Condition or disease Intervention/treatment Phase
Paediatric Stroke Drug: Methylprednisolone Drug: Prednisolone Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-center, randomized, controlled, non-blinded trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) Trial
Actual Study Start Date : November 16, 2021
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Steroids + Standard of care
Standard of care (including aspirin) and intravenous steroids, followed by oral tapering.
 Drug: Methylprednisolone
At the time of inclusion, intravenous Methylprednisolone for 3 days. Dose: 30 mg/kg/day (max. 1000 mg/dose)
Other Name: Solu-Medrol

Drug: 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)

Other Name: Spiricort
No Intervention: Standard of care
Standard of care (including aspirin)


Outcome Measures
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Primary Outcome Measures :
  1. Change in Focal Cerebral Arteriopathy Severity Score (FCASS) from baseline [ Time Frame: 1 month (30 days) ]

    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



Secondary Outcome Measures :
  1. Functional impairment outcome measured by Pediatric Stroke Outcome Measure (PSOM) [ Time Frame: 1, 3, 6 and 12 months ]

    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


  2. Recovery assessed by Recovery and Recurrence Questionnaire (RRQ) [ Time Frame: 1, 3, 6, and 12 months ]

    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


  3. Degree of disability or dependence by modified Rankin Scale (mRS) [ Time Frame: 1, 3, 6, and 12 months ]
    Minimum score (best outcome): 0 Maximum baseline score (worst outcome): 6

  4. Clinical outcome by Vineland adaptive behavior scale (VABS) [ Time Frame: 6 and 12 months ]

    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)


  5. Change in FCASS (Focal Cerebral Arteriopathy Severity Score) from baseline [ Time Frame: 6 months ]

    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


  6. Volume of stroke [ Time Frame: baseline, 1, 3 (if imaging is available) and 6 months ]

    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


  7. Residual vasculopathy [ Time Frame: 6 months ]

    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


  8. Stroke recurrence after index stroke [ Time Frame: 1, 6 and 12 months ]

    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)


  9. Stroke recurrence after index stroke in relation to the initial degree of vessel stenosis [ Time Frame: 6 and 12 months ]

    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.


  10. Stroke Quality of Life Measure (PSQLM) [ Time Frame: 12 month ]
    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)

  11. Preschool Wechsler Intelligence Scale for Children (WISC V) / Wechsler Preschool and Primary Scale of Intelligence (WIPPSI IV) [ Time Frame: 12 month ]
    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)

  12. Delis-Kaplan Executive Function System (D-KEFS) [ Time Frame: 12 month ]
    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)

  13. Continuous performance task (CPT-III) [ Time Frame: 12 month ]
    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)


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04873583


Contacts
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Contact: Maja Steinlin, Dr. med. +41 31 6329424 maja.steinlin@insel.ch
Contact: Leonie Steiner +41316329587 leonie.steiner@insel.ch

Locations
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Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Investigators
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Principal Investigator: Maja Steinlin, Dr. med. Bern university hospital, Inselspital Bern, Kinderklinik
More Information
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04873583    
Other Study ID Numbers: 1473_PASTA
2021-005571-39 ( EudraCT Number )
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It is not planned to share individual participant data to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
Ischemic
Stroke
Pediatric
Steroids
Unilateral
 Focal
Arteriopathy
Neurology
Cerebral
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
 Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents