Perioperative GFAP and Neurological Complications After Carotid Endarterectomy

NCT07843979 | Recruiting

• 1 other identifier: GFAP-KEA-2025-01
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-center observational study will evaluate whether blood levels of glial fibrillary acidic protein (GFAP), a protein associated with injury to supporting cells in the brain, are related to neurological complications after carotid endarterectomy. Adults aged 35 to 90 years undergoing elective isolated carotid endarterectomy will be enrolled. Serum GFAP will be measured before surgery and 24 hours after surgery. Investigators will record perioperative clinical information and postoperative neurological outcomes, including transient ischemic attack, stroke, delirium, and cognitive dysfunction. Approximately 90 participants are planned. The study will not assign any treatment or procedure.

Conditions

Carotid Stenosis

Keywords

Glial Fibrillary Acidic Protein; Carotid Endarterectomy; Postoperative Neurological Complications; Cerebral Oximetry

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Postoperative Neurological Complications

  Number of participants who experience at least one postoperative neurological complication after carotid endarterectomy: transient ischemic attack, stroke, delirium, or cognitive dysfunction. A participant with more than one event will be counted once in this composite outcome.

  At hospital discharge

Study Arms (1)

Carotid Endarterectomy Cohort

Adults undergoing elective isolated carotid endarterectomy. Serum GFAP is measured before surgery and 24 hours after surgery, and participants are observed for postoperative neurological complications.

Diagnostic Test: Serum GFAP Measurement

Interventions

Serum GFAP Measurement DIAGNOSTIC_TEST

Serum glial fibrillary acidic protein (GFAP) is measured before carotid endarterectomy and 24 hours after surgery. The measurements are collected for observational analysis and do not determine the participant's clinical care.

Carotid Endarterectomy Cohort

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with carotid artery disease who are scheduled for elective isolated carotid endarterectomy and are treated at the Cardiovascular Surgery Clinic of Bursa Yuksek Ihtisas Training and Research Hospital.

You may qualify if:

• Age 35 to 90 years
• Scheduled to undergo elective isolated carotid endarterectomy
• Willing and able to provide informed consent and the required blood samples

You may not qualify if:

• Acute coronary syndrome within the previous 3 months
• Carotid endarterectomy planned in combination with another surgical procedure
• Atrial fibrillation
• Known inflammatory disease
• Hematologic disease
• Refusal to provide preoperative consent or a blood sample
• Stroke with residual neurological sequelae within the previous year
• Multiple sclerosis, Alzheimer disease, Parkinson disease, or another pre-existing neurological disease

Sponsors & Collaborators

• Filiz Ata: lead

Study Sites (1)

University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Bursa, 16310, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Filiz Ata

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filiz Ata

CONTACT

+90 505 631 49 68; filizatafiliz@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 28, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 28, 2026

Record last verified: 2026-09

Locations

TU (1)