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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to evaluate recanalization treatments use, safety and efficacy at the acute phase of arterial ischemic stroke in pediatric patients
Arterial ischemic stroke outcomes benefited from the implementation of recanalization treatments (IV thrombolysis, endovascular treatments) and adapted management pathways in adult patients. Nevertheless randomized trials did not enroll patients under the age of 18 years old and data concerning these treatments in children are scarce. As it is much less frequent than in adults, recognition of stroke is often delayed in children. Consequently, acute phase trials are difficult to set up and perform. The phase I multicentric international prospective trial TIPS (Thrombolysis in Pediatric Stroke) was prematurely stopped because of poor enrollment. Published retrospective regional (Paris-Ile-de-France region, France) and national (Switzerland) studies addressed the feasibility of such treatments but, because of small samples (less than 20 patients in each study), efficiency and prognostic factors could not be addressed.
Exhaustive retrospective studies in a definite geographic area but with a sufficient number of patients in a limited inclusion period would provide these crucial data and address these questions with good relevance and limited bias.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arterial ischemic stroke in patients less than 18 years old | Patients < 18 years old
|
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| Measure | Description | Time Frame |
|---|---|---|
| Acute management of stroke: | Median time from symptom onset to Imaging (minutes) | 1 day |
| Acute management of stroke: | Median time from symptom onset to beginning of recanalization treatment (minutes) | 1 day |
| Acute management of stroke: | Median door-to-needle delay (minutes) | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events: | Intracranial hemorrhage (yes/no) | 7 days |
| Treatment-emergent adverse events: | clinically symptomatic (yes/no) |
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Inclusion Criteria:
Exclusion Criteria:
- Refusal of the patient's legal representative to participate in the study
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Patients aged less than 18 yo with arterial ischemic stroke and recanalization treatment at the acute phase, treated in France during the study period. Sample recruited from pediatric and adult databases of child neurology, stroke, and interventional radiology units
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| Name | Affiliation | Role |
|---|---|---|
| Manoelle Kossorotoff, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Necker- Enfants Malades Hospital | Paris | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36107427 | Result | Kossorotoff M, Kerleroux B, Boulouis G, Husson B, Tran Dong K, Eugene F, Damaj L, Ozanne A, Bellesme C, Rolland A, Bourcier R, Triquenot-Bagan A, Marnat G, Neau JP, Joriot S, Perez A, Guillen M, Perivier M, Audic F, Hak JF, Denier C, Naggara O; KidClot Group. Recanalization Treatments for Pediatric Acute Ischemic Stroke in France. JAMA Netw Open. 2022 Sep 1;5(9):e2231343. doi: 10.1001/jamanetworkopen.2022.31343. | |
| 39351662 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 7 days |
| Treatment-emergent adverse events: | Peripheral hemorrhage (yes/no) | 7 days |
| factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis | age of onset (year, months) | 12 months |
| factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis | Mechanism of stroke (CASCADE classification) | 12 months |
| factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis | stroke location (name of artery territory) | 12 months |
| factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis | time from symptom onset to beginning of recanalization treatment (minutes) | 12 months |
| factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis | initial imagine ASPECT Alberta Stroke Program Early CT Score. score (units on an scale). The ASPECTS score is a 10-point quantitative topographic CT scan score used in patients with middle cerebral artery (MCA) stroke. I has also been adapted to be used with MR scans. All scale ranges : Segmental assessment of the MCA vascular territory is made and 1 point is deducted from the initial score of 10 for every region involved (caudate, putamen, internal capsule, nsular cortex, M1(anterior MCA cortex=frontal operculum), M2(MCA cortex lateral to insular ribbon=anterior temporal lobe), M3(posterior MCA cortex=posterior temporal lobe, M4(anterior MCA territory immediately superior to M1), M5(lateral MCA territory immediately superior to M2), M6(posterior MCA territory immediately superior to M3) For each scale, values better or worse : In adults, an ASPECTS score less than or equal to 7 predicts a worse functional outcome at 3 months as well as symptomatic hemorrhage | 12 months |
| factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis | Association with :Modified Rankin Scale - mRS (Units on a scale)The mRS is a 6-point quantitative measure of functional independence. All scale ranges: 0=No symptoms at all
For each scales range, values better or worse : In the literature, good outcome is usually considered for patients with mRS [0-2]. Very good outcome is considered for patients with mRS [0-1]. We will use the same thresholds | 12 months |
| factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis | Association with : - The Pediatric Stroke Outcome Measure - PSOM (Units on a scale) =scale has been designed and published to quantify functional consequences of stroke in children. The PSOM is a detailed neurological examination, with outcome scored in terms of degree of impairment in each of language, cognition, and sensorimotor. We wil use the PSOM-SNE version (PSOM-Short Neuro Exam version). All scale ranges (0-0,5-1 or 2): - Sensorimotor deficit, Language Deficit - Production, Language Deficit - Comprehension, Cognitive or Behavioural Deficit. Total score on 10 For each scale range, values better or worse: Total impairment scores (out of a maximum of 10) will be considered as previously published, i.e. total score 0 or 0.5 representing good outcome, and poor outcome ≥1. All subscales ranges (Normal, Anormal, Not Done): Level of consciousness, Behaviour, mental status, Language, Cranial nerves, Motor testing, Tendon reflexes, Fine motor coordination, Sensory, Gate | 12 months |
| Derived |
| 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. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |