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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03887143
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date January 10, 2019
First Posted Date March 22, 2019
Last Update Posted Date November 22, 2021
Actual Study Start Date April 4, 2019
Actual Primary Completion Date May 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 21, 2019)
  • Acute management of stroke: [ Time Frame: 1 day ]
    Median time from symptom onset to Imaging (minutes)
  • Acute management of stroke: [ Time Frame: 1 day ]
    Median time from symptom onset to beginning of recanalization treatment (minutes)
  • Acute management of stroke: [ Time Frame: 1 day ]
    Median door-to-needle delay (minutes)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 15, 2019)
  • Treatment-emergent adverse events: [ Time Frame: 7 days ]
    Intracranial hemorrhage (yes/no)
  • Treatment-emergent adverse events: [ Time Frame: 7 days ]
    clinically symptomatic (yes/no)
  • Treatment-emergent adverse events: [ Time Frame: 7 days ]
    Peripheral hemorrhage (yes/no)
  • factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis [ Time Frame: 12 months ]
    age of onset (year, months)
  • factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis [ Time Frame: 12 months ]
    Mechanism of stroke (CASCADE classification)
  • factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis [ Time Frame: 12 months ]
    stroke location (name of artery territory)
  • 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)
  • 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
  • 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
    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
  • 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
Original Secondary Outcome Measures
 (submitted: March 21, 2019)
  • Treatment-emergent adverse events: [ Time Frame: 7 days ]
    Intracranial hemorrhage (yes/no)
  • Treatment-emergent adverse events: [ Time Frame: 7 days ]
    clinically symptomatic (yes/no)
  • Treatment-emergent adverse events: [ Time Frame: 7 days ]
    Peripheral hemorrhage (yes/no)
  • Factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis [ Time Frame: 12 months ]
    Age of onset (year, months)
  • Factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis [ Time Frame: 12 months ]
    Mechanism of stroke (CASCADE classification)
  • Factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis [ Time Frame: 12 months ]
    Stroke location (name of artery territory)
  • 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)
  • Factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis [ Time Frame: 12 months ]
    Initial imaging ASPECT score (Units on a scale)
  • 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)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Arterial Ischemic Stroke
Intervention Not Provided
Study Groups/Cohorts 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 19, 2021)
70
Original Estimated Enrollment
 (submitted: March 21, 2019)
80
Actual Study Completion Date May 29, 2021
Actual Primary Completion Date May 29, 2021   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03887143
Other Study ID Numbers NI18025HLJ
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Manoelle Kossorotoff, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date November 2021