IPSS Consortium Study

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Deepti Warad, M.B.B.S.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Deepti Warad, M.B.B.S.

Closed for enrollment

More information

Publications

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