|In Development |Clinical Trial |Multi-Site study | Maja Steinlin, Stéphane Chabrier & Manoëlle Kossorotoff |
The main goal of PASTA is to determine if a short high dose course of Methylprednisolone/Prednisolone (three intravenous pulses followed by a 4-week oral taper) + standard of care results in quicker recovery during the first year in children aged 6 months to 18 years with arterial ischemic stroke due to FCA vs. standard of care alone. Recovery is defined by a Paediatric Recurrence & Recovery Questionnaire total score £0.5 points, which represents good outcome. Secondary objectives are to compare in both groups at 6, 12, 24 and 36 months: 1) functional outcome by face-to-face visits; 2) arteriopathic course (FCAS score); 3) recurrence of stroke, epilepsy, neurological and developmental sequels, and academic achievement; 4) outcome by age group; 5) familial impact and lived experience of parents; 6) serious adverse events. PASTA has been identified as the most important AIS treatment trial by paediatric stroke experts and is designed as a pragmatic trial. It will provide high-level evidence for treatment of FCA. Monitoring a large cohort of children with FCA is an opportunity to increase our knowledge of long-term quantitative and qualitative consequences of childhood stroke, which is needed to deserve this familial approach and to identify those who will benefit from specific guidance and service.
Keywords: Focal cerebral arteriopathy (FCA), High dose steroids, Interventional study, Longitudinal study