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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
The Prediction of Adverse Events After Microsurgery for Intracranial Unruptured Aneurysms (PRAEMIUM) Study
Secondary ID [1] 0 0
PRAEMIUM
Universal Trial Number (UTN)
Trial acronym
PRAEMIUM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aneurysm, Brain 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
modified Rankin Scale
Timepoint [1] 0 0
Within 24 hours of admission to discharge, assessed up to 30 days
Primary outcome [2] 0 0
Sensorimotor neurological deficits
Timepoint [2] 0 0
Within 24 hours of admission to discharge, assessed up to 30 days
Primary outcome [3] 0 0
Clavien Dindo Complication Grading
Timepoint [3] 0 0
Within 24 hours of admission to discharge, assessed up to 30 days

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* No specific exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2022
Actual
Sample size
Target
4000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [2] 0 0
Macquarie University - Sydney
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Wisconsin
Country [9] 0 0
Austria
State/province [9] 0 0
Innsbruck
Country [10] 0 0
Austria
State/province [10] 0 0
Linz
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Germany
State/province [13] 0 0
Dresden
Country [14] 0 0
Germany
State/province [14] 0 0
Düsseldorf
Country [15] 0 0
Germany
State/province [15] 0 0
Frankfurt
Country [16] 0 0
Germany
State/province [16] 0 0
Göttingen
Country [17] 0 0
Germany
State/province [17] 0 0
Köln
Country [18] 0 0
Germany
State/province [18] 0 0
Mainz
Country [19] 0 0
Italy
State/province [19] 0 0
Florence
Country [20] 0 0
Italy
State/province [20] 0 0
Genoa
Country [21] 0 0
Italy
State/province [21] 0 0
Messina
Country [22] 0 0
Italy
State/province [22] 0 0
Milan
Country [23] 0 0
Italy
State/province [23] 0 0
Padova
Country [24] 0 0
Italy
State/province [24] 0 0
Roma
Country [25] 0 0
Italy
State/province [25] 0 0
Verona
Country [26] 0 0
Netherlands
State/province [26] 0 0
Amsterdam
Country [27] 0 0
Netherlands
State/province [27] 0 0
Leiden
Country [28] 0 0
Netherlands
State/province [28] 0 0
Utrecht
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Moscow
Country [30] 0 0
Sweden
State/province [30] 0 0
Göteborg
Country [31] 0 0
Switzerland
State/province [31] 0 0
Bern
Country [32] 0 0
Switzerland
State/province [32] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Other
Name
University of Zurich
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Macquarie University, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Melbourne
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Kepler University Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Medical University Innsbruck
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
General University Hospital, Prague
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Universitätsklinikum Köln
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Goethe University
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
University Medical Center Mainz
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
University of Göttingen
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
University Hospital Dresden
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Charite University, Berlin, Germany
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Heinrich-Heine University, Duesseldorf
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
University of Roma La Sapienza
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
University of Padova
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
University of Florence
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Other
Name [16] 0 0
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Address [16] 0 0
Country [16] 0 0
Other collaborator category [17] 0 0
Other
Name [17] 0 0
University of Messina
Address [17] 0 0
Country [17] 0 0
Other collaborator category [18] 0 0
Other
Name [18] 0 0
Universita di Verona
Address [18] 0 0
Country [18] 0 0
Other collaborator category [19] 0 0
Other
Name [19] 0 0
Uniuversity of Genua, Italy
Address [19] 0 0
Country [19] 0 0
Other collaborator category [20] 0 0
Other
Name [20] 0 0
Leiden University Medical Center
Address [20] 0 0
Country [20] 0 0
Other collaborator category [21] 0 0
Other
Name [21] 0 0
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Address [21] 0 0
Country [21] 0 0
Other collaborator category [22] 0 0
Other
Name [22] 0 0
UMC Utrecht
Address [22] 0 0
Country [22] 0 0
Other collaborator category [23] 0 0
Other
Name [23] 0 0
Burdenko Neurosurgery Institute
Address [23] 0 0
Country [23] 0 0
Other collaborator category [24] 0 0
Other
Name [24] 0 0
Sahlgrenska University Hospital, Sweden
Address [24] 0 0
Country [24] 0 0
Other collaborator category [25] 0 0
Other
Name [25] 0 0
University of Bern
Address [25] 0 0
Country [25] 0 0
Other collaborator category [26] 0 0
Other
Name [26] 0 0
Barrow Neurological Institute
Address [26] 0 0
Country [26] 0 0
Other collaborator category [27] 0 0
Other
Name [27] 0 0
Stanford University
Address [27] 0 0
Country [27] 0 0
Other collaborator category [28] 0 0
Other
Name [28] 0 0
Emory University
Address [28] 0 0
Country [28] 0 0
Other collaborator category [29] 0 0
Other
Name [29] 0 0
University of Wisconsin, Madison
Address [29] 0 0
Country [29] 0 0
Other collaborator category [30] 0 0
Other
Name [30] 0 0
University of California, San Francisco
Address [30] 0 0
Country [30] 0 0
Other collaborator category [31] 0 0
Other
Name [31] 0 0
University of Illinois at Chicago
Address [31] 0 0
Country [31] 0 0
Other collaborator category [32] 0 0
Other
Name [32] 0 0
Brigham and Women's Hospital
Address [32] 0 0
Country [32] 0 0
Other collaborator category [33] 0 0
Other
Name [33] 0 0
Mayo Clinic
Address [33] 0 0
Country [33] 0 0
Other collaborator category [34] 0 0
Other
Name [34] 0 0
University of California, Los Angeles
Address [34] 0 0
Country [34] 0 0
Other collaborator category [35] 0 0
Other
Name [35] 0 0
NorthShore University HealthSystem
Address [35] 0 0
Country [35] 0 0
Other collaborator category [36] 0 0
Other
Name [36] 0 0
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address [36] 0 0
Country [36] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04819074
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Victor Staartjes
Address 0 0
USZ
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Victor Staartjes
Address 0 0
Country 0 0
Phone 0 0
+41 44 255 2660
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04819074