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Prediction of Outcomes After Surgery for Unruptured Intracranial Aneurysms (PRAEMIUM)

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ClinicalTrials.gov Identifier: NCT04819074
Recruitment Status : Not yet recruiting
First Posted : March 26, 2021
Last Update Posted : April 29, 2021
Sponsor:
Collaborators:
Macquarie University, Australia
University of Melbourne
Kepler University Hospital
Medical University Innsbruck
General University Hospital, Prague
Universitätsklinikum Köln
University Hospital, Frankfurt
University Medical Center Mainz
University of Göttingen
University Hospital Dresden
Charite University, Berlin, Germany
Heinrich-Heine University, Duesseldorf
University of Roma La Sapienza
University of Padova
University of Florence
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
University of Messina
Universita di Verona
Uniuversity of Genua, Italy
Leiden University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
UMC Utrecht
Burdenko Neurosurgery Institute
Sahlgrenska University Hospital, Sweden
University of Bern
Barrow Neurological Institute
Stanford University
Emory University
University of Wisconsin, Madison
University of California, San Francisco
University of Illinois at Chicago
Brigham and Women's Hospital
Mayo Clinic
University of California, Los Angeles
NorthShore University HealthSystem
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment
Aneurysm, Brain Procedure: Microsurgery

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Prediction of Adverse Events After Microsurgery for Intracranial Unruptured Aneurysms (PRAEMIUM) Study
Estimated Study Start Date : May 20, 2021
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

Procedure: Microsurgery
Microsurgery for unruptured intracranial aneurysm




Primary Outcome Measures :
  1. modified Rankin Scale [ Time Frame: Within 24 hours of admission to discharge, assessed up to 30 days ]
    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.

  2. Sensorimotor neurological deficits [ Time Frame: Within 24 hours of admission to discharge, assessed up to 30 days ]
    Any new sensorimotor neurological deficits after surgery will be captured.

  3. Clavien Dindo Complication Grading [ Time Frame: Within 24 hours of admission to discharge, assessed up to 30 days ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Exclusion Criteria:

  • No specific exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04819074


Contacts
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Contact: Victor Staartjes +41 44 255 2660 praemium@usz.ch

Locations
Show Show 37 study locations
Sponsors and Collaborators
University of Zurich
Macquarie University, Australia
University of Melbourne
Kepler University Hospital
Medical University Innsbruck
General University Hospital, Prague
Universitätsklinikum Köln
University Hospital, Frankfurt
University Medical Center Mainz
University of Göttingen
University Hospital Dresden
Charite University, Berlin, Germany
Heinrich-Heine University, Duesseldorf
University of Roma La Sapienza
University of Padova
University of Florence
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
University of Messina
Universita di Verona
Uniuversity of Genua, Italy
Leiden University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
UMC Utrecht
Burdenko Neurosurgery Institute
Sahlgrenska University Hospital, Sweden
University of Bern
Barrow Neurological Institute
Stanford University
Emory University
University of Wisconsin, Madison
University of California, San Francisco
University of Illinois at Chicago
Brigham and Women's Hospital
Mayo Clinic
University of California, Los Angeles
NorthShore University HealthSystem
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
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Principal Investigator: Victor Staartjes USZ
Principal Investigator: Giuseppe Esposito USZ
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04819074    
Other Study ID Numbers: PRAEMIUM
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
machine learning
unruptured aneurysm
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases