National Retrospective Study Of Recanalization Treatments In Pediatric Arterial Ischemic Stroke

Arterial Ischemic Stroke Clinical Trial

— KID-CLOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887143
• Other study ID #: NI18025HLJ
• Status: Completed
• Start date: April 4, 2019
• Est. completion date: May 29, 2021

Study information

• Verified date: November 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 29, 2021
• Est. primary completion date: May 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
France	Necker- Enfants Malades Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute management of stroke:	Median time from symptom onset to Imaging (minutes)	1 day
Primary	Acute management of stroke:	Median time from symptom onset to beginning of recanalization treatment (minutes)	1 day
Primary	Acute management of stroke:	Median door-to-needle delay (minutes)	1 day
Secondary	Treatment-emergent adverse events:	Intracranial hemorrhage (yes/no)	7 days
Secondary	Treatment-emergent adverse events:	clinically symptomatic (yes/no)	7 days
Secondary	Treatment-emergent adverse events:	Peripheral hemorrhage (yes/no)	7 days
Secondary	factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis	age of onset (year, months)	12 months
Secondary	factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis	Mechanism of stroke (CASCADE classification)	12 months
Secondary	factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis	stroke location (name of artery territory)	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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