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临床试验/NCT07043777
NCT07043777已完成不适用

A Retrospective Chart-Review Evaluating Direct Three-Vessel Antegrade Cerebral Perfusion Versus Unilateral Right Axillary Antegrade Cerebral Perfusion in Emergency Total Arch Replacement for Acute Type A Aortic Dissection at CMUH (2021-2025)

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
201
试验地点
2
主要终点
Postoperative Stroke

研究概览

简要总结

This single-centre retrospective observational cohort study describes the technical feasibility of direct three-vessel antegrade cerebral perfusion, designated modified antegrade cerebral perfusion (MACP), during emergency total arch replacement for acute type A aortic dissection. MACP delivers antegrade cerebral perfusion directly to the brachiocephalic, left common carotid, and left subclavian arteries. Outcomes are summarised descriptively and compared exploratorily with unilateral right axillary antegrade cerebral perfusion (uACP). Because perfusion strategy and treating surgeon were completely confounded, the comparative analyses are intended only to contextualise the technical experience and generate hypotheses.

详细描述

Background and Rationale

Acute type A aortic dissection requires emergency surgical repair. When total arch replacement is performed, cerebral protection during circulatory arrest is usually provided with hypothermia and antegrade cerebral perfusion. The optimal branch-level configuration of antegrade cerebral perfusion in emergency arch repair remains uncertain.

This study evaluates a direct three-vessel antegrade cerebral perfusion strategy, designated modified antegrade cerebral perfusion (MACP). MACP was delivered using balloon-tipped catheters inserted into the brachiocephalic, left common carotid, and left subclavian arteries and connected to a three-line manifold from the cardiopulmonary bypass pump. The comparator was unilateral antegrade cerebral perfusion delivered through right axillary artery cannulation (uACP).

Study Design and Population

This is a single-centre retrospective observational cohort study conducted at China Medical University Hospital, Taichung, Taiwan. Consecutive adults aged 18 years or older who underwent emergency surgical repair for acute type A aortic dissection between 1 January 2021 and 30 April 2025 were identified from electronic health records and intraoperative perfusion records. The manuscript analytic cohort was restricted to patients undergoing emergency total arch replacement with either MACP or uACP.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 18 years or older.
  • •Patients who underwent emergency total arch replacement for acute type A aortic dissection at China Medical University Hospital between 1 January 2021 and 30 April
  • •Patients who received either direct three-vessel antegrade cerebral perfusion (MACP) or unilateral right axillary antegrade cerebral perfusion (uACP).

排除标准

  • •Incomplete key clinical, operative, or outcome data precluding analysis.
  • •Preoperative modified Rankin Scale score of 4 or higher.
  • •Ischemic stroke within 30 days before surgery.
  • •Remote prior stroke history or unavailable prior-stroke status.
  • •Patients managed with cerebral perfusion strategies other than MACP or uACP.

研究组 & 干预措施

Direct Three-Vessel ACP (MACP) Group

Patients undergoing emergency total arch replacement for acute type A aortic dissection in whom direct three-vessel antegrade cerebral perfusion was delivered to the brachiocephalic, left common carotid, and left subclavian arteries.

干预措施: Direct Three-Vessel Antegrade Cerebral Perfusion (MACP) (Procedure)

Unilateral Right Axillary ACP (uACP) Group

Patients undergoing emergency total arch replacement for acute type A aortic dissection in whom antegrade cerebral perfusion was delivered unilaterally through right axillary artery cannulation.

干预措施: Unilateral Right Axillary Antegrade Cerebral Perfusion (uACP) (Procedure)

结局指标

主要结局

Postoperative Stroke

时间窗: During the index admission, up to hospital discharge.

Postoperative stroke during the index admission, defined as an abrupt focal neurological deficit due to cerebral infarction or intracranial haemorrhage confirmed on postoperative computed tomography or magnetic resonance imaging and adjudicated by a consultant neurologist.

Postoperative Stroke

时间窗: Through hospital discharge (average about 14 days post-surgery)

New-onset cerebrovascular accident or imaging-confirmed stroke occurring after surgery and before hospital discharge. Diagnosis based on neurological examination and/or postoperative brain CT/MRI.

次要结局

  • In-Hospital Mortality(During the index admission, up to hospital discharge.)
  • Hospital Length of Stay(From surgery to hospital discharge.)
  • ICU Length of Stay(From postoperative ICU admission to ICU discharge during the index admission.)
  • Mechanical Ventilation Duration(During the index admission, up to liberation from invasive ventilation.)
  • Postoperative Acute Kidney Injury (AKI)(Within 7 postoperative days.)
  • Dialysis Requirement(During the index admission, up to hospital discharge.)
  • Number of Participants Requiring Re-operation for Bleeding(During the index admission, up to hospital discharge.)
  • Number of Participants with Sepsis (Sepsis-3)(During the index admission, up to hospital discharge.)
  • Number of Participants with Postoperative Atrial Fibrillation(During the index admission, up to hospital discharge.)
  • Tracheostomy(During the index admission, up to hospital discharge.)
  • Hospital Length of Stay(From end of surgery to discharge (max 30 days))
  • Postoperative Neurological Deficit(Through hospital discharge (average about 14 days post-surgery))
  • 30-Day Mortality(Assessed at 30 days post-surgery)
  • ICU Length of Stay(From end of surgery to ICU discharge (max 14 days))
  • Mechanical Ventilation Duration(From end of surgery until extubation (max 120 hours))
  • Postoperative Acute Kidney Injury (AKI)(Through index hospitalization (average 10-14 days))
  • Dialysis Requirement(Through index hospitalization (average 10-14 days))
  • Myocardial Infarction(Through index hospitalization (average 10-14 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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