National Retrospective Study Of Recanalization Treatments In Pediatric Arterial Ischemic Stroke (KID-CLOT)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Arterial Ischemic Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT03887143

NI18025HLJ

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Ages: Under 18 years old

Volunteers: No 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

Trial design

70 participants in 1 patient group

Arterial ischemic stroke in patients less than 18 years old

Description:

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