Prospective Registry of Acute Ischemic Stroke in Children Under 18 Years Old in China

Official title

Prospective Registry of Acute Ischemic Stroke in Children Under 18 Years Old in China (KIDS-AIS-REGISTRY)

Overview

This observational study aims to investigate the real-world effectiveness and safety of different treatment strategies for acute ischemic stroke (AIS) in Chinese children under 18 years of age. Its primary research question is: In real-world clinical practice, does endovascular therapy (e.g., stent retriever thrombectomy, aspiration thrombectomy) improve 90-day functional outcomes in pediatric AIS patients with acute anterior or posterior circulation large vessel occlusion? Children under 18 years of age receiving routine AIS diagnosis and treatment at approximately 25-35 study centers across China will undergo neurological function assessments, imaging examinations, and evaluations of growth, development, and psychosocial status at baseline, 24 hours post-procedure, 7 days post-procedure or at hospital discharge, and at 90 days and 6 months post-onset. Adverse events will also be documented.

Interventions

• Other Standard Clinical Management
  Participants receive routine clinical care per each center's standard practice. Treatment may include medical therapy (antiplatelet agents, anticoagulation) and/or endovascular treatment (stent retriever, aspiration thrombectomy, balloon angioplasty, stenting, or intra-arterial thrombolysis), as determined by the treating physician. No protocol-mandated intervention is applied.

Primary outcome measures

• Pediatric Modified Rankin Scale (ped-mRS) Score at 90 Days [Time frame: 90 days (±7 days) post-stroke onset]

Secondary outcome measures (3)

• Proportion of Patients with ped-mRS 0-1, 0-2, 0-3 at 90 Days [Time frame: 90 days (±7 days) post-stroke onset]
• Change in ped-NIHSS Score at 24 Hours [Time frame: 24 hours (±12 hours) post-procedure]
• Pediatric Modified Rankin Scale (ped-mRS) Score at 6 Months [Time frame: 6 months (±14 days) post-stroke onset]

Eligibility criteria

Inclusion criteria

• Age >28 days and <18 years;
• Presence of stroke-related symptoms (hemiparesis, facial palsy, aphasia, altered level of consciousness, seizure, headache) or atypical symptoms (sudden lethargy or irritability, crying, feeding difficulties, incontinence, sensory loss, ataxia, vertigo, nausea and/or vomiting, neck pain, fever);
• First-ever stroke and onset within ≤7 days prior to admission;
• Acute ischemic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI);
• Legal guardian provides signed informed consent;
• For children aged ≥8 years to <18 years who are conscious and without comprehension impairment, assent obtained from the child;

Exclusion criteria

• Lack of imaging examination or stroke diagnosed without imaging
• History of hypoxic-ischemic encephalopathy
• Ischemic stroke caused by cerebral venous system
• Concurrent presence of indistinguishable ischemic and hemorrhagic stroke

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Chandra RV, Leslie-Mazwi TM, Mehta BP, Derdeyn CP, Demchuk AM, Menon BK, Goyal M, Gonzalez RG, Hirsch JA. Does the use of IV tPA in the current era of rapid and predictable recanalization by mechanical embolectomy represent good value? J Neurointerv Surg. 2016 May;8(5):443-6. doi: 10.1136/neurintsurg-2015-012231. Epub 2016 Jan 12. PMID 26758911
• Puetz V, Khomenko A, Hill MD, Dzialowski I, Michel P, Weimar C, Wijman CA, Mattle HP, Engelter ST, Muir KW, Pfefferkorn T, Tanne D, Szabo K, Kappelle LJ, Algra A, von Kummer R, Demchuk AM, Schonewille WJ; Basilar Artery International Cooperation Study (BASICS) Group. Extent of hypoattenuation on CT angiography source images in basilar artery occlusion: prognostic value in the Basilar Artery Intern PMID 21960577
• Barber PA, Demchuk AM, Zhang J, Buchan AM. Validity and reliability of a quantitative computed tomography score in predicting outcome of hyperacute stroke before thrombolytic therapy. ASPECTS Study Group. Alberta Stroke Programme Early CT Score. Lancet. 2000 May 13;355(9216):1670-4. doi: 10.1016/s0140-6736(00)02237-6. PMID 10905241
• Goyal M, Fargen KM, Turk AS, Mocco J, Liebeskind DS, Frei D, Demchuk AM. 2C or not 2C: defining an improved revascularization grading scale and the need for standardization of angiography outcomes in stroke trials. J Neurointerv Surg. 2014 Mar;6(2):83-6. doi: 10.1136/neurintsurg-2013-010665. Epub 2013 Feb 6. No abstract available. PMID 23390038
• Zhang W, Zhu B, Cai G, Niu M, Duan C, Zhang P, Xu Y, Xiao L, Li Q, Su Z, Wu F, Li W, Wang H, Sun W. Current status and prognostic factors of paediatric arterial ischaemic stroke in China: a study protocol for Chinese Paediatric Ischaemic Stroke Registry (CPISR). BMJ Open. 2025 Jun 18;15(6):e093718. doi: 10.1136/bmjopen-2024-093718. PMID 40533220
• Tudorache R, Kossorotoff M, Kerleroux B, Denier C, Naggara O, Boulouis G; KID-CLOT Group. Determinants of Timely Access to Recanalization Treatments and Outcomes in Pediatric Ischemic Stroke. Stroke. 2024 Nov;55(11):2716-2719. doi: 10.1161/STROKEAHA.124.046417. Epub 2024 Oct 1. PMID 39351662
• Sporns PB, Bhatia K, Abruzzo T, Pabst L, Fraser S, Chung MG, Lo W, Othman A, Steinmetz S, Jensen-Kondering U, Schob S, Kaiser DPO, Marik W, Wendl C, Kleffner I, Henkes H, Kraehling H, Nguyen-Kim TDL, Chapot R, Yilmaz U, Wang F, Hafeez MU, Requejo F, Limbucci N, Kauffmann B, Mohlenbruch M, Nikoubashman O, Schellinger PD, Musolino P, Alawieh A, Wilson J, Grieb D, Gersing AS, Liebig T, Olivieri M, Sc PMID 39401507
• Sporns PB, Fullerton HJ, Lee S, Kirton A, Wildgruber M. Current treatment for childhood arterial ischaemic stroke. Lancet Child Adolesc Health. 2021 Nov;5(11):825-836. doi: 10.1016/S2352-4642(21)00167-X. Epub 2021 Jul 29. PMID 34331864

Identifiers

NCT: NCT07550257 · 2026GSFYLS017

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗