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Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03887143
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase
Start date April 4, 2019
Completion date May 29, 2021

See also
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Completed NCT04962503 - A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) Phase 2