Predictors of Post-clamping Neurologic Deficits During Carotid Endarterectomy With Regional Anesthesia

April 13, 2020 updated by: João Rocha Neves, Universidade do Porto

Preoperative, Intraoperative and Postoperative Predictors of Post-clamping Neurologic Deficits During Carotid Endarterectomy With Regional Anesthesia

Patients undergoing carotid endarterectomy may suffer from neurologic deficits (ND) during the carotid cross-clamping due to cerebral hypoperfusion. An associated risk of postoperative stroke incidence is also well established.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing carotid endarterectomy may suffer from neurologic deficits (ND) during the carotid cross-clamping due to cerebral hypoperfusion. An associated risk of postoperative stroke incidence is also well established.

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.

Study Type

Observational

Enrollment (Anticipated)

206

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Portugal
      • Porto, Portugal, 4200 - 319
        • Recruiting
        • Faculdade de Medicina da Universidade do Porto
        • Contact:
          • DEpartamento FMUP, MD
          • Phone Number: (+351) 22 551 3600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Post-clamping deficits were defined as any persistent alteration at neurologic examination during the CACC and resistant to hemodynamic adjustment

Description

Inclusion Criteria:

  • carotid endarterectomy under regional anesthesia
  • Postclamping carotid deficit

Exclusion Criteria:

  • carotid stenting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Procedure: 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
Procedure: carotid endarterectomy
shunt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke
Time Frame: up to 5 years
An episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction.
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clavien-Dindo Classification >3
Time Frame: 30 days
Postoperative event life threatining and requiring surgical, endoscopic or radiological intervention
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiosvascular and cerebrovascular events
Time Frame: up to 5 years
AMI, Stroke, AHF hospitalization, MALE, MACE, All-cause mortality
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2030

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

April 13, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 13, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

after ethics and data manager authorization

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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