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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04819074
Registration number
NCT04819074
Ethics application status
Date submitted
18/03/2021
Date registered
26/03/2021
Date last updated
21/12/2021
Titles & IDs
Public title
Prediction of Outcomes After Surgery for Unruptured Intracranial Aneurysms
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Scientific title
The Prediction of Adverse Events After Microsurgery for Intracranial Unruptured Aneurysms (PRAEMIUM) Study
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Secondary ID [1]
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PRAEMIUM
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Universal Trial Number (UTN)
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Trial acronym
PRAEMIUM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aneurysm, Brain
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Surgery - Microsurgery
Patients with unruptured brain aneurysms - We will include all adult patients (18 years or older) undergoing microsurgical treatment for UIAs. No specific exclusion criteria will be set. Patients with prior SAH may only be included when surgical treatment occurred at least 4 weeks after ictus. Only patients treated from January 1st 2010 onwards can be included in this study.
No intervention.
Treatment: Surgery: Microsurgery
Microsurgery for unruptured intracranial aneurysm
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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modified Rankin Scale
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Assessment method [1]
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Neurological outcome was assessed by the modified Rankin scale (mRS), and a favorable neurological outcome was defined as mRS 0, 1, or 2. The scale runs from 0 to 5, and higher scores mean a worse outcome.
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Timepoint [1]
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Within 24 hours of admission to discharge, assessed up to 30 days
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Primary outcome [2]
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Sensorimotor neurological deficits
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Assessment method [2]
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Any new sensorimotor neurological deficits after surgery will be captured.
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Timepoint [2]
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Within 24 hours of admission to discharge, assessed up to 30 days
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Primary outcome [3]
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Clavien Dindo Complication Grading
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Assessment method [3]
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Complications will be assessed using the modified 2009 Clavien-Dindo grading (CDG), and occurrence of a complication was defined as any deviation from CDG 0. The CDG runs from 0 to 5, and higher scores mean a worse complication.
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Timepoint [3]
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Within 24 hours of admission to discharge, assessed up to 30 days
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Eligibility
Key inclusion criteria
- Adult patients (18 or older)
- Undergone microsurgical treatment for unruptured intracranial aneurysm
- Patients with prior SAH may only be included when surgical treatment occurred at least
4 weeks after ictus.
- Treated from January 1st 2010 onwards
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
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Key exclusion criteria
- No specific exclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2022
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Actual
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Sample size
Target
4000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [2]
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Macquarie University - Sydney
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment postcode(s) [2]
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- Sydney
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Recruitment outside Australia
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Arizona
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California
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Wisconsin
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Austria
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Innsbruck
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Austria
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Linz
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Czechia
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Praha
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Düsseldorf
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Germany
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Frankfurt
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Germany
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Göttingen
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Germany
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Köln
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Germany
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Mainz
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Italy
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Florence
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Italy
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Genoa
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Italy
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Messina
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Italy
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Milan
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Italy
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Padova
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Italy
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Roma
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Italy
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Verona
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Netherlands
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Amsterdam
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Leiden
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Netherlands
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Utrecht
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Russian Federation
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Moscow
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Sweden
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Göteborg
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Switzerland
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Bern
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Switzerland
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Zürich
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Funding & Sponsors
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Other
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Name
University of Zurich
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Macquarie University, Australia
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University of Melbourne
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Kepler University Hospital
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Medical University Innsbruck
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General University Hospital, Prague
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Universitätsklinikum Köln
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Goethe University
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University Medical Center Mainz
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University of Göttingen
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University Hospital Dresden
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Charite University, Berlin, Germany
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Other
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Heinrich-Heine University, Duesseldorf
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University of Roma La Sapienza
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University of Padova
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University of Florence
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Other
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
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Other
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University of Messina
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Other
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Universita di Verona
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Uniuversity of Genua, Italy
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Other
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Leiden University Medical Center
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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UMC Utrecht
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Burdenko Neurosurgery Institute
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Sahlgrenska University Hospital, Sweden
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University of Bern
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Barrow Neurological Institute
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Stanford University
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Emory University
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University of Wisconsin, Madison
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University of California, San Francisco
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University of Illinois at Chicago
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Brigham and Women's Hospital
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Mayo Clinic
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University of California, Los Angeles
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NorthShore University HealthSystem
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Ethics approval
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Summary
Brief summary
Accurate preoperative identification of patients at high risk for adverse outcomes would be
clinically advantageous, as it would allow enhanced resource preparation, better surgical
decision-making, enhanced patient education and informed consent, and potentially even
modification of certain modifiable risk factors. The aim of the Prediction of adverse events
after microsurgery for intracranial unruptured aneurysms (PRAEMIUM) study is therefore to
develop and externally validate a clinically applicable, robust ML-based prediction tool
based on multicenter data from a range of international centers.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04819074
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Victor Staartjes
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USZ
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Contact person for public queries
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Victor Staartjes
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Phone
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+41 44 255 2660
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04819074
Download to PDF