Prediction of Outcomes After Surgery for Unruptured Intracranial Aneurysms
PRAEMIUM
The Prediction of Adverse Events After Microsurgery for Intracranial Unruptured Aneurysms (PRAEMIUM) Study
1 other identifier
observational
4,000
9 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2021
CompletedFirst Posted
Study publicly available on registry
March 26, 2021
CompletedStudy Start
First participant enrolled
May 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedDecember 21, 2021
December 1, 2021
8 months
March 18, 2021
December 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
modified Rankin Scale
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.
Within 24 hours of admission to discharge, assessed up to 30 days
Sensorimotor neurological deficits
Any new sensorimotor neurological deficits after surgery will be captured.
Within 24 hours of admission to discharge, assessed up to 30 days
Clavien Dindo Complication Grading
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.
Within 24 hours of admission to discharge, assessed up to 30 days
Study Arms (1)
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.
Interventions
Microsurgery for unruptured intracranial aneurysm
Eligibility Criteria
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.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zurichlead
- Macquarie University, Australiacollaborator
- University of Melbournecollaborator
- Kepler University Hospitalcollaborator
- Medical University Innsbruckcollaborator
- General University Hospital, Praguecollaborator
- Universitätsklinikum Kölncollaborator
- Goethe Universitycollaborator
- University Medical Center Mainzcollaborator
- University of Göttingencollaborator
- University Hospital Dresdencollaborator
- Charite University, Berlin, Germanycollaborator
- Heinrich-Heine University, Duesseldorfcollaborator
- University of Roma La Sapienzacollaborator
- University of Padovacollaborator
- University of Florencecollaborator
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Bestacollaborator
- University of Messinacollaborator
- Universita di Veronacollaborator
- University of Genua, Italycollaborator
- Leiden University Medical Centercollaborator
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)collaborator
- UMC Utrechtcollaborator
- Burdenko Neurosurgery Institutecollaborator
- Sahlgrenska University Hospitalcollaborator
- University of Berncollaborator
- Barrow Neurological Institutecollaborator
- Stanford Universitycollaborator
- Emory Universitycollaborator
- University of Wisconsin, Madisoncollaborator
- University of California, San Franciscocollaborator
- University of Illinois at Chicagocollaborator
- Brigham and Women's Hospitalcollaborator
- Mayo Cliniccollaborator
- University of California, Los Angelescollaborator
- Endeavor Healthcollaborator
- Fondazione Policlinico Universitario Agostino Gemelli IRCCScollaborator
Study Sites (37)
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
UCLA
Los Angeles, California, 90095, United States
UCSF
San Francisco, California, 94143, United States
Stanford University
Stanford, California, 94305, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
University of Illinois
Chicago, Illinois, 60612, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Royal Melbourne Hospital
Melbourne, Australia
Macquarie University
Sydney, Australia
Innsbruck University
Innsbruck, Austria
Linz Kepler Klinikum
Linz, Austria
Prague University
Prague, Czechia
Charité Univesitätsmedizin
Berlin, Germany
University of Cologne
Cologne, Germany
Dresden Uniklinikum
Dresden, Germany
Düsseldorf Universitätsmedizin
Düsseldorf, Germany
Frankfurt University
Frankfurt, Germany
Universitätsmedizin Göttingen
Göttingen, Germany
Unimedizin Mainz
Mainz, Germany
University of Florence - Careggi
Florence, Italy
University of Genoa
Genoa, Italy
University of Messina
Messina, Italy
Carlo Besta
Milan, Italy
Padova University
Padua, Italy
Gemelli University Hospital
Roma, Italy
Sapienza University
Roma, Italy
University of Verona
Verona, Italy
Amsterdam UMC
Amsterdam, Netherlands
Leiden University
Leiden, Netherlands
UMC Utrecht
Utrecht, Netherlands
Burdenko Hospital
Moscow, Russia
Sahlgrenska Hospital
Gothenburg, Sweden
Inselspital Bern
Bern, Switzerland
University Hospital Zurich
Zurich, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victor Staartjes
USZ
- PRINCIPAL INVESTIGATOR
Giuseppe Esposito
USZ
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2021
First Posted
March 26, 2021
Study Start
May 20, 2021
Primary Completion
January 1, 2022
Study Completion
October 1, 2022
Last Updated
December 21, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share