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临床试验/NCT07424976
NCT07424976Enrolling By Invitation不适用

Early Detection of Brain Damage in Children With Congenital Heart Disease After Cardiovascular Surgery

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月3日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
1
主要终点
Concentration of serum brain injury biomarker concentrations (ELISA panel)

研究概览

简要总结

Infants with congenital heart disease undergoing cardiac surgery with extracorporeal circulation are at risk for perioperative hypoxic-ischaemic brain injury. This prospective, single-centre observational cohort study will evaluate perioperative dynamics of serum biomarkers of neuronal, glial, and axonal injury and relate biomarker patterns to postoperative EEG changes and brain MRI findings, aiming to improve early detection of brain injury and identify children at higher risk of hypoxic encephalopathy.

详细描述

This prospective observational study will enrol 30 children up to 1 year of age with congenital heart disease requiring surgery with extracorporeal circulation at a single paediatric intensive care centre. After parental/guardian consent, peripheral blood will be collected for ELISA measurement of secretoneurin, GFAP, neuron-specific enolase, S100B, UCHL-1, neurofilament light chain, and total tau at the following time points: within 24 hours preoperatively; 1 hour after arrival from the operating theatre; and 24, 48, 72, 96 hours and 7 days postoperatively. All participants will undergo EEG within the first 24 hours and on postoperative day 7. Between postoperative week 1 and week 2, 15 participants will undergo brain MRI under sedation or general anaesthesia. Perioperative and postoperative clinical variables will be abstracted (e.g., cardiopulmonary bypass duration, major artery clamp duration, inotrope/vasoactive support, arrhythmias, and markers of organ hypoperfusion including lactate and regional oxygen saturation). Associations between biomarker trajectories and EEG/MRI evidence of brain injury will be assessed using repeated-measures modelling; ROC analyses will explore biomarker thresholds where applicable.

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
10 Days 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Infants/children up to 1 year of age with congenital heart disease undergoing surgery requiring extracorporeal blood circulation (cardiopulmonary bypass).

排除标准

  • Congenital heart disease not requiring extracorporeal circulation during surgery
  • Inoperable congenital heart defect
  • Hypoxic encephalopathy at birth requiring therapeutic hypothermia

研究组 & 干预措施

1 (single cohort; no control group)

Infants (≤1 year) with congenital heart disease undergoing cardiac surgery requiring extracorporeal circulation.

干预措施: Observational study: blood analisys, EEG, MRI (Other)

结局指标

主要结局

Concentration of serum brain injury biomarker concentrations (ELISA panel)

时间窗: Within 24 hours pre-op; 1 hour post-op arrival; 24, 48, 72, 96 hours; and 7 days post-op.

Serum concentrations of secretoneurin, GFAP, NSE, S100B, UCHL-1, neurofilament light chain, and total tau measured in peripheral blood.

Number of Participants with postoperative EEG abnormalities

时间窗: Post-op day 0-1 and post-op day 7

EEG findings assessed within the first 24 hours and on postoperative day 7

Presence and types of intracranial injuries seen on brain MRI (subset)

时间窗: Post-op week 1-2.

Presence/type/frequency of brain MRI findings performed in a subset of 15 participants between postoperative week 1 and week 2

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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