Condition: Paediatric Stroke · Sponsor: Insel Gruppe AG, University Hospital Bern
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.
This description comes directly from the study's public registry record.
Maja Steinlin, Dr. med. · +41 31 6329424 · maja.steinlin@insel.ch
Kathrin Bochud, PhD · +41316643472 · kathrin.zuercher@insel.ch
Always discuss trial participation with your own doctor first.
| 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 Pädiatrie 1 A.ö. Landeskrankenhaus/ Universitätskliniken Innsbruck | Innsbruck, Tyrol, Austria | Not Yet Recruiting |
| Johannes Kepler University Linz, Med Campus IV, Univ.-Klinik für Kinder- und Jugendheilkunde | Linz, Upper Austria, Austria | Not Yet Recruiting |
| Universitätsklinik für Kinder und Jugendheilkunde Wien | Vienna, Austria | Recruiting |
| Børn og Unge - Aarhus Universitetshospital | Aarhus, Denmark | Not Yet 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 |
| Pediatric Neurology Strasbourg - Hautepierre University Hospital | Strasbourg, Alsace, France | Recruiting |
| Hôpital Femme Mère Enfant Lyon | Bron, Auvergne-Rhône-Alpes, France | Recruiting |
| Hôpital Roger Salengro, CHRU de Lille | Lille, France | Recruiting |
+ 23 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04873583