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
|Condition or disease||Intervention/treatment|
|Aneurysm, Brain||Procedure: Microsurgery|
|Study Type :||Observational|
|Estimated Enrollment :||4000 participants|
|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|
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.
Microsurgery for unruptured intracranial aneurysm
- 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.
- 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.
- 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.
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
|Contact: Victor Staartjes||+41 44 255 email@example.com|
|Principal Investigator:||Victor Staartjes||USZ|
|Principal Investigator:||Giuseppe Esposito||USZ|