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

National Retrospective Study Of Recanalization Treatments In Pediatric Arterial Ischemic Stroke (Intra-venous Thrombolysis and/or Endovascular Treatment: Thrombectomy, Intra-arterial Thrombolysis)

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

Study Overview

• Status: Completed
• Conditions: Arterial Ischemic Stroke

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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Necker- Enfants Malades Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Arterial ischemic stroke in patients less than 18 years old; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute management of stroke:	Median time from symptom onset to Imaging (minutes)	1 day
Acute management of stroke:	Median time from symptom onset to beginning of recanalization treatment (minutes)	1 day
Acute management of stroke:	Median door-to-needle delay (minutes)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent adverse events:	Intracranial hemorrhage (yes/no)	7 days
Treatment-emergent adverse events:	clinically symptomatic (yes/no)	7 days
Treatment-emergent adverse events:	Peripheral hemorrhage (yes/no)	7 days
factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis	age of onset (year, months)	12 months
factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis	Mechanism of stroke (CASCADE classification)	12 months
factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis	stroke location (name of artery territory)	12 months
factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis	time from symptom onset to beginning of recanalization treatment (minutes)	12 months
factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis	initial imagine ASPECT Alberta Stroke Program Early CT Score. score (units on an scale). The ASPECTS score is a 10-point quantitative topographic CT scan score used in patients with middle cerebral artery (MCA) stroke. I has also been adapted to be used with MR scans. All scale ranges : Segmental assessment of the MCA vascular territory is made and 1 point is deducted from the initial score of 10 for every region involved (caudate, putamen, internal capsule, nsular cortex, M1(anterior MCA cortex=frontal operculum), M2(MCA cortex lateral to insular ribbon=anterior temporal lobe), M3(posterior MCA cortex=posterior temporal lobe, M4(anterior MCA territory immediately superior to M1), M5(lateral MCA territory immediately superior to M2), M6(posterior MCA territory immediately superior to M3) For each scale, values better or worse : In adults, an ASPECTS score less than or equal to 7 predicts a worse functional outcome at 3 months as well as symptomatic hemorrhage	12 months
factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis	Association with :Modified Rankin Scale - mRS (Units on a scale)The mRS is a 6-point quantitative measure of functional independence. All scale ranges: 0=No symptoms at all; No significant disability despite symptoms; able to carry out all usual duties and activities; Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance disability; requiring some help, but able to walk without assistance; Moderate; Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requiring constant nursing care and attention; Dead For each scales range, values better or worse : In the literature, good outcome is usually considered for patients with mRS [0-2]. Very good outcome is considered for patients with mRS [0-1]. We will use the same thresholds	12 months
factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis	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	12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Manoelle Kossorotoff, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 4, 2019
• Primary Completion (ACTUAL): May 29, 2021
• Study Completion (ACTUAL): May 29, 2021

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (ACTUAL): March 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: thrombolysis; children; Ischemic stroke; thrombectomy; recanalization treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: NI18025HLJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No