Necker- Enfants Malades Hospital
Paris, 75015, France
NCT Number: NCT03887143
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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Notify MeUp to 18 year
All sexes
Observational
Paris, 75015, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 day
Median time from symptom onset to Imaging (minutes)
Time frame: 1 day
Median time from symptom onset to beginning of recanalization treatment (minutes)
Time frame: 1 day
Median door-to-needle delay (minutes)
Time frame: 7 days
Intracranial hemorrhage (yes/no)
Time frame: 7 days
clinically symptomatic (yes/no)
Time frame: 7 days
Peripheral hemorrhage (yes/no)
Time frame: 12 months
age of onset (year, months)
Time frame: 12 months
Mechanism of stroke (CASCADE classification)
Time frame: 12 months
stroke location (name of artery territory)
Time frame: 12 months
time from symptom onset to beginning of recanalization treatment (minutes)
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
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
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
Time frame: 12 months
Association with :
All scale ranges (0-0,5-1 or 2):
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
Assistance Publique - Hôpitaux de Paris
Other
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
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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