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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age28-18
SponsorGansu Provincial Maternal and Child Health Care Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Standard Clinical Management

Treatment groups

1,000 Participants
are divided into 1 treatment group

Locations

This trial has no locations