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IPSS Consortium Study

Overview

Información sobre este estudio

The overall objective of our network of investigators is to develop and conduct clinical trials and other large multi-centre studies in childhood stroke. Our specific aims are:

Objective 1: To ascertain in a prospective, consecutive cohort study the numbers of newborns and children with ischemic stroke, their stroke sub-types and risk factors, their current treatments and outcomes within our centers. These data will provide the rationale and feasibility data for our group to design and implement the initial randomized controlled trials (RCTs) in paediatric stroke as well as other fundable grant proposals.

Objective 2: To develop standardized data collection forms and an appropriate database with web-based data entry from multiple study sites.

Objective 3: To develop standardized protocols for (1) diagnosis, (2) investigation of risk factors, (3) outcome assessment and 4) antithrombotic therapies of neonates and children with arterial ischemic stroke (AIS) and cerebral sinovenous thrombosis (CSVT)

Objective 4: Obtain grant funding to support and conduct additional multi-centre IPSS sub-studies

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Research authorization in place, and
  • A patient will be eligible for the study if s/he meets all of the following criteria for either stroke type:

AIS (Acute Ischemic Stroke)

  • Age: term birth (gestation > 36 weeks) to 18 years of age
  • Event diagnosed after January 1st, 2003
  • Must have both clinical and radiological evidence present:
    • Focal neurological deficit of acute onset lasting greater than 20 minutes, and computed tomography (CT) or magnetic resonance imaging (MRI) showing infarct in location consistent with neurological signs and symptoms
    • Neonates: seizures or lethargy alone may be the only acute symptom, and CT or MRI showing infarct
    • Haemorrhagic infarction (ischemic infarct with secondary haemorrhage)
    • Hypoxic ischemic event with diffuse or bilateral infarction, if there is in addition a definite focal, single arterial infarct in a specified vascular territory. (e.g. middle cerebral artery, or MCA, mentioned in the radiographic report.)

CSVT (Cerebral Sinovenous Thrombosis)

  • Age: birth (premature infants included) to 18 years of age
  • Event diagnosed after January 1st, 2003
  • Must have both clinical and radiological evidence present:
    • Clinical criteria: any transient neurological dysfunction including:
      • headache, seizure, decreased level of consciousness
      • focal neurological signs consistent with CSVT
    • Neuroimaging criteria: thrombosis of cerebral veins or venous sinuses seen on MRI, MR venography, CT venography

Exclusion Criteria: 

  • A patient who meets any of the following criteria will not be eligible for the study:
    • Cerebral haemorrhage not associated with ischemic infarct.
    • Hypoxic ischemic event with diffuse or bilateral infarction alone (not associated with one of the above conditions).

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Deepti Warad, M.B.B.S.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20309707

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