National Retrospective Study Of Recanalization Treatments In Pediatric Arterial Ischemic Stroke

Completed

• Conditions: Arterial Ischemic Stroke

• Registration Number: NCT03887143
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-22
• Study Start: 2019-04-04
• Primary Completion: 2021-05-29
• Study Completion: 2021-05-29
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute management of stroke:	1 day	Median door-to-needle delay (minutes)

Secondary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events:	7 days	Peripheral hemorrhage (yes/no)
factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis	12 months	Association with : - The Pediatric Stroke Outcome Measure - PSOM (Units on a scale) =scale has been designed and published to quantify functional consequences of stroke in children. The PSOM is a detailed neurological examination, with outcome scored in terms of degree of impairment in each of language, cognition, and sensorimotor. We wil use the PSOM-SNE version (PSOM-Short Neuro Exam version).; All scale ranges (0-0,5-1 or 2): - Sensorimotor deficit, Language Deficit - Production, Language Deficit - Comprehension, Cognitive or Behavioural Deficit. Total score on 10; For each scale range, values better or worse: Total impairment scores (out of a maximum of 10) will be considered as previously published, i.e. total score 0 or 0.5 representing good outcome, and poor outcome ≥1.; All subscales ranges (Normal, Anormal, Not Done): Level of consciousness, Behaviour, mental status, Language, Cranial nerves, Motor testing, Tendon reflexes, Fine motor coordination, Sensory, Gate

Trial Locations

Locations (1)

Necker- Enfants Malades Hospital; 🇫🇷 Paris, France