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NCT Number: NCT04347785

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.

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Key information

Conditions

Carotid Endarterectomy Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculdade de Medicina da Universidade do Porto

Porto, 4200 - 319, Portugal

Location status: Recruiting

Location contact

DEpartamento FMUP, MD

CONTACT

(+351) 22 551 3600

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • carotid endarterectomy under regional anesthesia
  • Postclamping carotid deficit

Exclusion criteria

  • carotid stenting

Treatment and study plan

carotid endarterectomy

Procedure

shunt

Primary outcomes

  1. Stroke

    Time frame: up to 5 years

    An episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction.

Secondary outcomes

  1. Clavien-Dindo Classification >3

    Time frame: 30 days

    Postoperative event life threatining and requiring surgical, endoscopic or radiological intervention

Other outcomes

  1. Major adverse cardiosvascular and cerebrovascular events

    Time frame: up to 5 years

    AMI, Stroke, AHF hospitalization, MALE, MACE, All-cause mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Joao P Rocha-Neves, MD, MSC; MPH, FEBVS

CONTACT

[email protected]

+351910486230

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2020
Study completion
2030
First posted
Apr 15, 2020
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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