IPSS Consortium Study
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-004802
Sponsor Protocol Number: 16-004802
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 |
|
More information
Publications
Publications are currently not available