National Retrospective Study Of Recanalization Treatments In Pediatric Arterial Ischemic Stroke

National Retrospective Study Of Recanalization Treatments In Pediatric Arterial Ischemic Stroke (Intra-venous Thrombolysis and/or Endovascular Treatment: Thrombectomy, Intra-arterial Thrombolysis)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03887143

Acronym

KID-CLOT

Enrollment

Registered

2019-03-22

Start date

2019-04-04

Completion date

2021-05-29

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Ischemic Stroke

Keywords

Ischemic stroke, children, recanalization treatment, thrombolysis, thrombectomy

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Acute management of stroke:	1 day	Median time from symptom onset to Imaging (minutes)

Secondary

Measure	Time frame	Description
Treatment-emergent adverse events:	7 days	Intracranial hemorrhage (yes/no)
factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis	12 months	age of onset (year, months)

Countries

France

Outcome results