– Results from Save ChildS Pro Registry study
Evidence gap:
Stroke affects 1.3-1.6 per 100,000 children annually. It necessitates rapid recognition, often through standardised clinical scoring tools such as Face, Arms, Speech, Time (FAST), or the Pediatric NIH Stroke Scale (NIHSS), to initiate treatment.
RCPCH 2017 Stroke guidelines recommend thrombolysis 4.5 hours from stroke onset and endovascular thrombectomy (EVT), if onset-to-arterial puncture is within 5 hours, or up to 12 hours when neuroimaging is favourable.
Meta-analysis of randomised controlled trials (RCTs) in adult populations showed the benefit of EVT in acute ischemic stroke. However, due to physiologic differences in adults compared to children, specifically the suspected stroke aetiology (i.e. ischemic stroke in children is more likely from a cardioembolic source or arteriopathy) and expected recovery (children thought to have greater neuroplasticity), the translatability of these findings was unclear.
Retrospective data (Save ChildS study, French KidClot study) have confirmed the safety and efficacy of EVT in children. Paediatric stroke RCTs face significant barriers – from the rarity of stroke events and difficulty in recruiting and buy-in for treatment (see: premature termination of the Thrombolysis in Pediatric Stroke [TIPS] trial), and already proven significant treatment effect of EVT in adults. Thus, the authors chose to address the question in this prospective cohort study.
CASP Q1 – Did the study address a clearly focused issue?
Yes. Save ChildS Pro Registry study prospectively compares functional outcomes with EVT + best medical treatment (BMT) vs BMT alone in children (28 days–18 years) with acute ischemic
The study:
Sporns PB, Bhatia K, Abruzzo T, Pabst L, Fraser S, Chung MG, Lo W, Othman A, Steinmetz S, Jensen-Kondering U, Schob S. Endovascular thrombectomy for childhood stroke (Save ChildS Pro): an international, multicentre, prospective registry study. The Lancet Child & Adolescent Health. 2024 Dec 1;8(12):882-90.https://doi.org/10.1016/S2352-4642(24)00233-5
Methods:
This was a multicenter prospective cohort (Registry) study with 45 international centres providing eligible patient data on children admitted with acute arterial ischemic stroke from January 1, 2020, to August 31, 2023. All patients in the study received the best medical treatment.
Participating centres prospectively committed and contributed to the rigorous and exhaustive collection of demographic data, outcome measures and ensured all etiological investigations were completed according to the Childhood AIS Standardised Classification and Diagnostic Evaluation (CASCADE) classification.
CASP Q2 – Was the cohort recruited in an acceptable way?
Yes
CASP Q3 – Was the exposure accurately measured to minimise bias?
Yes. EVT group = attempted groin puncture (even if failed); BMT = no EVT. Objective, consistent.
Results:
Out of 241 children enrolled in the registry, 208 were analysed. Patients without outcome data were excluded (13.7%). Of those, 117 patients underwent EVT, while 91 received the best medical treatment alone.
Some takeaways from group demographics as follows:
- There was no difference in intravenous thrombolysis or neuroimaging criteria (Alberta Stroke Program early CT score ASPECTS) between groups.
- Only 27% of patients received intravenous thrombolysis in the best medical practice group.
- The longest time to EVT was 9 hours, and the youngest patient to receive EVT was 3 months old.
- At baseline, the EVT group were older (median 11 y vs 6 y, p<0.0001), had higher PedNIHSS at admission (14 vs 9, p<0.0001), had different stroke aetiology (more cardioembolic in EVT, more focal arteriopathy in BMT, p<0.0001) and were more often treated at centres offering EVT (implied possible centre-level effect).
The authors accounted for these imbalances using ordinal regression, adjusting for all variables that were statistically different. Then they repeated the analysis after propensity score matching on age, sex, and severity, essentially creating more balanced subgroups.
Physicians in the registry favoured medical treatment alone for a subgroup of patients with focal arteriopathies. There was no difference in 90-day outcomes in this subpopulation.
CASP Q5a – Have the authors identified all important confounders?
Yes
CASP Q5b – Have they accounted for confounding in design/analysis?
Yes, partly. Residual confounding remains (e.g. aetiology, centre effects).
CASP Q6a – Was follow-up complete enough?
Yes
CASP Q6b – Was the follow-up long enough?
Probably no. 90-day follow-up may underestimate long-term paediatric neurodevelopmental outcomes.
Limitations:
Given the inability to conduct a pediatric stroke RCT, this was the closest the authors could come to demonstrating prospectively the efficacy of EVT.
Potential bias is inherent to an observational design; centre-specific effects could have driven the analysis.
Some centres appeared to select EVT in sicker patients. The authors argued that centres with no EVT procedures available could balance this. Physicians were not blinded to treatment, and there may have been selection bias with a lack of randomisation.
Another limitation was that the cohort was too small to do a subgroup analysis, which may have been particularly interesting for patients with focal arteriopathies or younger and more severely affected children. This is important, as age and severity of disability were also associated with outcome; we cannot conclude from this study without subgroup analysis whether this means that younger and more severely affected children benefit more from EVT or if this group drove more of the treatment effect.
Generalisability and Local Applicability:
This study has high external validity, with multiple sites included at varying levels of resources and proven benefit with minimal harm.
Specific to our centre, considerations for EVT have included determining the best location for the procedure. For example, whether EVTs should be done at the adult site where EVTs are done with higher volume, or onsite at the Children’s Hospital, where local pediatric anaesthetics and intensive care expertise are available.
Additional considerations include the age cut-off depending on local input/expertise, and multidisciplinary consensus on criteria for EVT eligibility (time after stroke and/or favourable neuroimaging).
Reflection & Next Steps:
- The decision on whether to perform EVT should not be based on one single parameter (such as the PedNIHSS), but rather on a combination of clinical parameters (i.e. PedNIHSS, neuroimaging and occlusion location, pre-existing neurological deficits).
- Further study is needed for focal cerebral arteriopathy
- EVT implementation locally should be guided by multidisciplinary discussion. Emerging research and procedures may help clarify common questions such as age cutoffs, timing/and neuroimaging parameters.
How does your local institution facilitate EVT? Tell us in the comments.
CASP Q7 – Do you believe the results?
Yes. Consistent across analyses; plausible biologically; align with prior paediatric and adult RCT data. But magnitude is uncertain due to non-randomisation, unblinded outcomes, and exclusions.
CASP Q8 – Can the results be applied to the local population?
Yes, with context
CASP Q9- Do the results fit with other available evidence?
Yes
About PICSTAR
PICSTAR is a trainee-led research network open to all doctors, nurses and allied health trainees within Paediatric Intensive Care. We are the trainee arm of the Paediatric Critical Care Society – Study Group (PCCS-SG) and work with them on research, audit and service evaluation.
If you would like to join PICSTAR and get involved in projects, have ideas you would like to propose or get advice/mentorship via PCCS-SG, don’t hesitate to contact us at picstar.network@gmail.com. See their website for more: https://pccsociety.uk/research/picstar/
References
Royal College of Paediatrics and Child Health. Stroke in childhood: clinical guideline for diagnosis, management and rehabilitation. London: RCPCH; 2017. Available from: https://www.rcpch.ac.uk/sites/default/files/2025-08/Stroke%20guideline%202017.pdf [Accessed 27 Aug 2025].
Sporns PB, Sträter R, Minnerup J, et al. Feasibility, Safety, and Outcome of Endovascular Recanalization in Childhood Stroke: The Save ChildS Study. JAMA Neurol. 2020;77(1):25–34. doi:10.1001/jamaneurol.2019.3403
Kossorotoff M, Kerleroux B, Boulouis G, et al. Recanalization Treatments for Pediatric Acute Ischemic Stroke in France. JAMA Netw Open. 2022;5(9):e2231343. doi:10.1001/jamanetworkopen.2022.31343
Critical Appraisal Skills Programme (2024). CASP checklist for Cohort studies [online] Available at:https://casp-uk.net/casp-checklists/CASP-checklist-cohort-study-2024.pdf . [Accessed: August 28 2025].
