Predictors of Post-clamping Neurologic Deficits During Carotid Endarterectomy With Regional Anesthesia
NCT ID: NCT04347785
Last Updated: 2020-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
206 participants
OBSERVATIONAL
2011-01-01
2030-12-31
Brief Summary
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The aim of this study is to evaluate the predictive factors associated with ND during CEA performed with RA. The perioperative implications of the ND were also evaluated.
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Detailed Description
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The aim of this study is to evaluate the predictive factors associated with ND during CEA performed with RA. The perioperative implications of the ND were also evaluated.
All consecutive patients from a tertiary referral center who underwent CEA for carotid artery stenosis (CS) and consecutive patients who presented alterations in the neurologic examination after ICA clamping during CEA are selected. The control patients, submitted to the same procedure but with no neurologic alterations, are consecutively selected.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Neurologic deficit
All consecutive patients from a tertiary referral center who underwent CEA for carotid artery stenosis who presented alterations in the neurologic examination after ICA clamping during CEA area selected
carotid endarterectomy
shunt
control
The control patients are submitted to the same procedure but with no neurologic alterations, are consecutively selected. a 1 to 1 ratio is used
carotid endarterectomy
shunt
Interventions
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carotid endarterectomy
shunt
Eligibility Criteria
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Inclusion Criteria
* Postclamping carotid deficit
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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Universidade do Porto
OTHER
Responsible Party
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João Rocha Neves
Consultant of Angiology and Vascular Surgery, MD/MSc, MPH epidemiology, FEBVS
Locations
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Faculdade de Medicina da Universidade do Porto
Porto, , Portugal
Countries
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Central Contacts
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Facility Contacts
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DEpartamento FMUP, MD
Role: primary
References
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Pereira-Macedo J, Rocha-Neves JP, Dias-Neto MF, Andrade JPV. Prognostic effect of troponin elevation in patients undergoing carotid endarterectomy with regional anesthesia - A prospective study. Int J Surg. 2019 Nov;71:66-71. doi: 10.1016/j.ijsu.2019.09.015. Epub 2019 Sep 19.
Vieira-Andrade JD, Rocha-Neves JP, Macedo JP, Dias-Neto MF. Onset of Neurological Deficit During Carotid Clamping With Carotid Endarterectomy Under Regional Anesthesia Is Not a Predictor of Carotid Restenosis. Ann Vasc Surg. 2019 Nov;61:193-202. doi: 10.1016/j.avsg.2019.05.025. Epub 2019 Aug 2.
Pereira-Macedo J, Duarte-Gamas L, Pereira-Neves A, de Andrade JJP, Rocha-Neves J. Short-term outcomes after selective shunt during carotid endarterectomy: a propensity score matching analysis. Neurocirugia (Engl Ed). 2024 Mar-Apr;35(2):71-78. doi: 10.1016/j.neucie.2023.07.006. Epub 2023 Sep 9.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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248-18
Identifier Type: -
Identifier Source: org_study_id
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