NCT03887143

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
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arterial Ischemic Stroke

Timeline

• Start date: 2019-04-04
• Primary completion: 2021-05-29
• Completion: 2021-05-29
• First posted: 2019-03-22
• Last updated: 2025-11-20

Locations

1 site across 1 country: France