Photo Credit: Helen Carlson, Ph.D, Alberta Children’s Hospital
International Pediatric Stroke Study (IPSS)
The International Pediatric Stroke Study (IPSS) is the world’s largest and most successful childhood stroke registry and network made up of dedicated clinicians, scientists and research staff from over 100 institutions in 34 countries. They have prospectively enrolled over 6,000 patients in an effort to conduct high-quality clinical and imaging research studies. The IPSS will continue to conduct transformational research with help and support from partner organization IPSO. Together, the IPSS and IPSO will provide the foundation for scientific and clinical collaborations, as well as advocate for the paediatric stroke community worldwide.
IPSO members are welcome to get involved with the IPSS. Learn more below!
In 2003, Dr. Gabrielle DeVeber at the Hospital for Sick Children, with 11 co-Investigators and a multi-center clinical research grant from the Child Neurology Society/Child Neurology Foundation, established the International Pediatric Stroke Study (IPSS), the world’s first pediatric stroke registry. During the initial 4 study years, 30 participating IPSS centers enrolled 1,187 neonates and children and published the first 8 IPSS papers informing pediatric stroke practice worldwide. With additional funding support from the National Institute of Neurological Disorders and Stroke (NINDS), philanthropic donors (The Auxilium Foundation), and other source funding for targeted studies on stroke classification (Ped-NIHSS, CASCADE), etiology (the Vascular Effects of Infection in Stroke, VIPS), thrombolytic safety (Thrombosis in Pediatric Stroke, TIPS), and seizures (Seizures in Pediatric Stroke, SIPS), the IPSS has expanded globally and recruited additional pediatric stroke experts from multiple disciplines in an effort to better understand, prevent, and improve outcomes in pediatric stroke.
The IPSS has since continued to serve as a highly successful study vehicle facilitating data entry from over 150 Investigators and Research Staff at 100 institutions across 34 countries worldwide. To date (2019), the IPSS Investigators have enrolled over 6,400 patients with ischemic stroke (including those at high risk of stroke) and have published over 30 papers.
Mission & Objectives
The missions of the IPSS are:
The main objective of the IPSS is to develop and conduct research to improve the care of children with stroke.
The specific objectives to promote this aim are to:
1. 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 pediatric stroke as well as other fundable grant proposals.
2. Develop standardized data collection forms and an appropriate database with web-based data entry from multiple study sites.
3. Develop standardized guidelines for (1) diagnosis, (2) investigation of risk factors, (3) outcome assessment,(4) antithrombotic therapies for neonates and children with arterial ischemic stroke (AIS) and cerebral sinovenous thrombosis (CSVT) and (5) partner with other relevant networks caring for stroke
4. Obtain funding to support and conduct additional multi-centre IPSS sub-studies
Please note that the IPSS objectives are currently being reviewed by IPSS and IPSO leadership committees to accommodate the growing needs of the IPSS Investigators and our IPSO partnership.
The IPSS Publications Committee (PC) was established for the purpose of enabling timely research publications whilst ensuring the maintenance of ethical standards, the primacy of patient privacy and fair distribution of authorship for academic contributors.
The PC strives to recognize all contributing Investigators through authorship on IPSS papers. Contribution may be in the form of patient recruitment or intellect (participation in study design, meeting attendance, sub-group participation, contribution to complex stroke case etc.).
Mentorship and assistance to co-authors is provided by the Publications Committee, where needed, specifically by the PC liaison.
Junior Investigators are a priority to the committee, for whom authorship is critical for academic promotion.
Grant-funded IPSS Studies
Seizures in Pediatric Stroke Study (SIPS)
The Seizures in Pediatric Stroke study (SIPS) seeks to learn more about acute seizures after pediatric stroke, with funding support from PERF (SIPS I, PI deVeber; SIPS II, PI Fox) . Phase I SIPS closed in 2014 after enrolling 142 patients at 21 centers. Phase II SIPS started enrollment in 2016 and completed in July 2018 with 160 patients. Follow-up data collection finished in August 2019. IPSS Central is preparing the SIPS II data package in anticipation of SIPS-specific research manuscripts, with oversight from the SIPS II Publications Committee.
Vascular effects of Infection in Pediatric Stroke (VIPS)
The Vascular Effects of Infection in Pediatric Stroke study (VIPS) investigates the role of infection in childhood ischemic strokes, with funding support from the NIH (VIPS I and VIPS II, PI Fullerton). VIPS I had a total budget of $7M, and VIPS II another $3.3M.
VIPS I closed enrollment in 2012 with 355 Cases at 39 centers. VIPS II has 22 nationwide enrolling sites and started its third year of enrollment in June 2019. To date, VIPS II has enrolled over 100 cases and 90 controls. Projected end date for enrollment is June 2021 with 200 pediatric stroke cases; follow-up data (1 year) will be collected until June 2022.
IPSS Central will prepare the VIPS II data package in late 2022 and publications will begin in early 2023.
Resources for IPSS Investigators
The IPSS clinical data is housed in the Research Electronic Data Capture (REDCap) data collection platform managed and maintained by IPSS Central at SickKids. The REDCap system provides secure, web-based applications that provide an intuitive interface for all users. REDCap was developed specifically around HIPAA-Security guidelines and is recommended to SickKids researchers by both our Privacy Office and Research Ethics Board.
Historically, IPSS clinical data was captured in Oracle (2003-2014). Since 2015, all clinical data has been captured in REDCap when the data collection form also developed to capture specific patient sub-groups and classifications of pediatric stroke.
Link to Clinical Database (REDCap): https://redcapexternal.research.sickkids.ca/
All imaging data is housed in the Stroke Imaging Lab for Children (SILC)–IPSS repository at SickKids. SILC will work in tandem with the IPSS data core to support the IPSS Imaging Repository and provide an attractive and secure platform for sites to transfer brain images and ensure the necessary security and processing measures are in place. Image files are to be securely transferred via the File Transfer Portal (FTP) from IPSS sites. These brain images will complement the clinical data that is stored in REDCap. Collectively, this data will provide a more robust and comprehensive dataset and high-caliber research papers.
Please contact IPSS Central for more details.