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Arterial Ischemic StrokeKID-CLOTNCT03887143

National Retrospective Study Of Recanalization Treatments In Pediatric Arterial Ischemic Stroke

An observational study of Arterial Ischemic Stroke, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Arterial Ischemic Stroke
How many people
70 participants
Where
1 siteFrance
Study dates
4 Apr 2019to 29 May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • 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

Who cannot join

  • Refusal of the patient's legal representative to participate in the study

Trial locations and contacts

1 site in 1 country.

France1 site

  • Necker- Enfants Malades Hospital

    Paris, Paris, 75015

Other trials in France

About this study

Official title: 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

Read the 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.

Keywords
Ischemic stroke, children, recanalization treatment, thrombolysis, thrombectomy
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03887143
Study groupRoleWhat they receive
Arterial ischemic stroke in patients less than 18 years oldPatients < 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute management of stroke:

    Median time from symptom onset to Imaging (minutes)

    Measured: 1 day

  2. Acute management of stroke:

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

    Measured: 1 day

  3. Acute management of stroke:

    Median door-to-needle delay (minutes)

    Measured: 1 day

Secondary outcomes (10)

  1. Treatment-emergent adverse events:

    Intracranial hemorrhage (yes/no)

    Measured: 7 days

  2. Treatment-emergent adverse events:

    clinically symptomatic (yes/no)

    Measured: 7 days

  3. Treatment-emergent adverse events:

    Peripheral hemorrhage (yes/no)

    Measured: 7 days

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

    age of onset (year, months)

    Measured: 12 months

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

    Mechanism of stroke (CASCADE classification)

    Measured: 12 months

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

    stroke location (name of artery territory)

    Measured: 12 months

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

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

    Measured: 12 months

  8. 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

    Measured: 12 months

  9. 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

    1. No significant disability despite symptoms; able to carry out all usual duties and activities
    2. 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
    3. Moderate
    4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    6. 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

    Measured: 12 months

  10. 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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2019
  2. Study start4 Apr 2019
  3. Primary completion29 May 2021
  4. Study completion29 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03887143
Sponsor's protocol ID
NI18025HLJ
Acronym
KID-CLOT
Status last verified
Oct 2025
First submitted
10 Jan 2019
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kossorotoff M, Kerleroux B, Boulouis G, Husson B, Tran Dong K, Eugene F, Damaj L, Ozanne A, Bellesme C, Rolland A, Bourcier R, Triquenot-Bagan A, Marnat G, Neau JP, Joriot S, Perez A, Guillen M, Perivier M, Audic F, Hak JF, Denier C, Naggara O; KidClot Group. Recanalization Treatments for Pediatric Acute Ischemic Stroke in France. JAMA Netw Open. 2022 Sep 1;5(9):e2231343. doi: 10.1001/jamanetworkopen.2022.31343.

    PubMed 36107427

  • Tudorache R, Kossorotoff M, Kerleroux B, Denier C, Naggara O, Boulouis G; KID-CLOT Group. Determinants of Timely Access to Recanalization Treatments and Outcomes in Pediatric Ischemic Stroke. Stroke. 2024 Nov;55(11):2716-2719. doi: 10.1161/STROKEAHA.124.046417. Epub 2024 Oct 1.

    PubMed 39351662

Questions about this trial

What is this clinical trial studying?

An observational study of Arterial Ischemic Stroke, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute management of stroke: (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03887143, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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