Investigation of the Association Between Perioperative Glial Fibrillary Acidic Protein Levels and Postoperative Neurological Complications After Carotid Endarterectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of Participants With Postoperative Neurological Complications
研究概览
简要总结
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.
详细描述
Patients scheduled for elective isolated carotid endarterectomy at Bursa Yuksek Ihtisas Training and Research Hospital will be prospectively observed. Serum GFAP will be measured before surgery and 24 hours after surgery. Recorded variables will include demographic characteristics, comorbidities, coronary artery disease, echocardiographic and routine laboratory findings, perioperative anesthetic medications, hemodynamic measurements, peripheral oxygen saturation, and cerebral oxygenation measured by near-infrared spectroscopy (NIRS). Postoperative observations will include bleeding, hematoma, transient ischemic attack, stroke, delirium, cognitive dysfunction, and serum GFAP values. Analyses will compare participants who develop a postoperative neurological complication with those who do not and will evaluate the association of GFAP measurements with neurological complications using univariable and multivariable logistic regression. This is a non-interventional study; all clinical care will be determined by the treating team.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 35 to 90 years
- •Scheduled to undergo elective isolated carotid endarterectomy
- •Willing and able to provide informed consent and the required blood samples
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Serum GFAP Measurement (Diagnostic Test)
结局指标
主要结局
Number of Participants With Postoperative Neurological Complications
时间窗: At hospital discharge
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.
次要结局
未报告次要终点
研究者
Filiz Ata
Associate Professor of Anesthesiology and Reanimation
Bursa Yuksek Ihtisas Training and Research Hospital