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Completed

NCT Number: NCT03887143

National Retrospective Study Of Recanalization Treatments In Pediatric Arterial Ischemic Stroke

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

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Necker- Enfants Malades Hospital

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Acute management of stroke:

    Time frame: 1 day

    Median time from symptom onset to Imaging (minutes)

  2. Acute management of stroke:

    Time frame: 1 day

    Median time from symptom onset to beginning of recanalization treatment (minutes)

  3. Acute management of stroke:

    Time frame: 1 day

    Median door-to-needle delay (minutes)

Secondary outcomes

  1. Treatment-emergent adverse events:

    Time frame: 7 days

    Intracranial hemorrhage (yes/no)

  2. Treatment-emergent adverse events:

    Time frame: 7 days

    clinically symptomatic (yes/no)

  3. Treatment-emergent adverse events:

    Time frame: 7 days

    Peripheral hemorrhage (yes/no)

  4. factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis

    Time frame: 12 months

    age of onset (year, months)

  5. factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis

    Time frame: 12 months

    Mechanism of stroke (CASCADE classification)

  6. factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis

    Time frame: 12 months

    stroke location (name of artery territory)

  7. factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis

    Time frame: 12 months

    time from symptom onset to beginning of recanalization treatment (minutes)

  8. factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis

    Time frame: 12 months

    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

  9. factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis

    Time frame: 12 months

    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

  10. factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: KID-CLOT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2019
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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