Clinical trial NCT03887143: National Retrospective Study Of Recanalization Treatments In Pediatric Arterial Ischemic Stroke
Official title: National Retrospective Study Of Recanalization Treatments In Pediatric Arterial Ischemic Stroke (Intra-venous Thrombolysis and/or Endovascular Treatment: Thrombectomy, Intra-arterial Thrombolysis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Ischemic Stroke
Keywords: Ischemic stroke
children
recanalization treatment
thrombolysis
thrombectomy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 70
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged less than 18 yo with arterial ischemic stroke and recanalization treatment at the acute phase, treated in France during the study period. Sample recruited from pediatric and adult databases of child neurology, stroke, and interventional radiology units

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute management of stroke:
timeFrame: 1 day
measure: Acute management of stroke:
timeFrame: 1 day
measure: Acute management of stroke:
timeFrame: 1 day
Secondary outcomes:
measure: Treatment-emergent adverse events:
timeFrame: 7 days
measure: Treatment-emergent adverse events:
timeFrame: 7 days
measure: Treatment-emergent adverse events:
timeFrame: 7 days
measure: factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis
timeFrame: 12 months
measure: factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis
timeFrame: 12 months
measure: factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis
timeFrame: 12 months
measure: factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis
timeFrame: 12 months
measure: factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis
timeFrame: 12 months
measure: factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis
timeFrame: 12 months
measure: factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker- Enfants Malades Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Manoelle Kossorotoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: