National Retrospective Study Of Recanalization Treatments In Pediatric Arterial Ischemic Stroke

NCT ID: NCT03887143

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-04

Study Completion Date

2021-05-29

Brief Summary

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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

Detailed Description

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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.

Conditions

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Arterial Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Arterial ischemic stroke in patients less than 18 years old

Patients \< 18 years old

* Suspected or confirmed cerebral infarction
* With recanalization treatment in the acute phase: intra-venous thrombolysis +/- intra-arterial thrombolysis +/- thrombectomy
* Patients treated between January 2015, 1st and May 2018, 31st

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients under 18 years old
* Suspected or confirmed cerebral infarction
* With recanalization treatment in the acute phase : intravenous thrombolysis +/- intra-arterial thrombolysis +/- thrombectomy
* Patients treated between the January 2015, 1st and the May 2018, 31st
* Collection of non-opposition from legal representatives

Exclusion Criteria

\- Refusal of the patient's legal representative to participate in the study
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manoelle Kossorotoff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Necker- Enfants Malades Hospital

Paris, Paris, France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 36107427 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39351662 (View on PubMed)

Related Links

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Other Identifiers

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NI18025HLJ

Identifier Type: -

Identifier Source: org_study_id

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