NotablePrimary and study completion dates: Dec 2020 to Dec 2030v32Show 7 more changesShow less
Eligibility criteria expanded, about 12 words
Secondary endpoint revised
Primary endpoints revised (2)
Study description expanded, about 20 words
Site contact updated
Collaborators shortened, about 8 words
Study title expanded, about 5 words
NotablePrimary endpoints: 1 to 2v31Show 5 more changesShow less
Start date: Jun 2004 to Jan 2003
Eligibility criteria expanded, about 218 words
Secondary endpoint revised
Publications: 4 to 5
Study description expanded, about 4 words
NotableLead sponsor: National Institute of Neurological Disorders and Stroke (NINDS) to The Hospital for Sick Childrenv30Show 9 more changesShow less
Enrollment target: 1 to 12000
Primary endpoint revised
Trial status: Completed to Recruiting
Study sites: 2 to 1
Primary completion date: Dec 2020
Study completion date: Sep 2011 to Dec 2020
Secondary endpoint revised
Study description shortened, about 9 words
Collaborators expanded, about 8 words
Show 28 earlier versionsHide 28 earlier versions
MinorStudy completion date: Sep 2011v29
4 versionsRe-verified since May 7, 2010, no change to tracked fieldsv25-v28
MinorTrial status: Active, Not Recruiting to Completed
Study sites: 7 to 2
v24
NotableEnrollment target: 5050 to 1
Primary completion date: May 2006 to not stated
v23
2 versionsRe-verified since Sep 2, 2009, no change to tracked fieldsv21-v22
MinorStudy completion date: May 2006 to not statedv20
MinorTrial status: Recruiting to Active, Not Recruiting
Site details revised at 7 of 7 sites
v19
MinorPrimary and study completion dates: May 2006v18
NotableEnrollment target: 50 to 5050v17
MinorPublications: 2 to 4v16
3 versionsRe-verified since Mar 3, 2008, no change to tracked fieldsv13-v15
Study Status, Outcome Measuresv12
Study Status, Study Design, Outcome Measuresv11
MinorEnrollment target: 50v10
MinorEnrollment target: 50 to not statedv9
2 versionsRe-verified since Feb 24, 2007, no change to tracked fieldsv7-v8
MinorStudy sites: 1 to 7
Study completion date: Jun 2006 to not stated
v6
2 versionsRe-verified since Aug 23, 2006, no change to tracked fieldsv4-v5
MinorStudy completion date: Jun 2005 to Jun 2006v3
MinorStudy completion date: Jun 2005
Start date: Jun 9, 2004 to Jun 2004
Site contact updated
Publications: 4 to 2
v2
Study First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The International Pediatric Stroke Study (IPSS) was established in 2003 as a multi-center, multi-national clinical research registry. Over the years, it has grown to become a highly successful study vehicle for pediatric stroke research across over 100 institutions worldwide. Today, The IPSS continues to serve as the global clinical data and imaging core for multi-disciplinary pediatric experts who perform international collaborative research to better understand, prevent, and improve outcomes in pediatric stroke. The robust dataset and cohesive network enable high caliber and ground-breaking research in the field.
Participating sites enroll neonates or children who have had an ischemic or hemorrhagic stroke, or may be at high risk of having a stroke. Participants have their medical and research records reviewed for information about their stroke and abstracted into a secure electronic database called REDCap, which is hosted at SickKids in Toronto Canada. The IPSS also provides an attractive imaging platform (through the Stroke Imaging Lab for Children, SILC, housed at SickKids) for sites to share clinically acquired brain images that will complement the clinical dataset. The clinical and imaging datasets will improve our understanding of the processes underlying plasticity and recovery in childhood stroke.