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Completed

NCT Number: NCT07043777

Three-Vessel Versus Unilateral Antegrade Cerebral Perfusion in Emergency Total Arch Replacement for Acute Type A Aortic Dissection

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

China Medical University Hospital

Taichung, 40447, Taiwan

About this study

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.

Objectives

The primary objective is to describe the technical feasibility of MACP during emergency total arch replacement for acute type A aortic dissection. A secondary objective is to provide exploratory contextual outcome comparisons between MACP and uACP. The study is retrospective and observational; the comparative analyses are intended to generate hypotheses rather than to establish treatment effects.

Outcome Measures

The index outcome for the exploratory comparison is 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. Secondary outcomes include in-hospital mortality, acute kidney injury, new dialysis, reoperation for bleeding, sepsis, postoperative atrial fibrillation, tracheostomy, mechanical ventilation duration, intensive care unit stay, and hospital stay.

Statistical Analysis

Continuous data are summarised as median and interquartile range, and binary data as n/N and percentage. Propensity scores for MACP were estimated using baseline covariates selected a priori and constrained by the small number of MACP patients. The primary exploratory comparison used 1:2 nearest-neighbour propensity score matching without replacement. Binary outcomes were analysed using Firth-penalised logistic regression, and continuous outcomes were compared using non-parametric methods with bootstrap confidence intervals. Sensitivity analyses examined alternative matching specifications, an unmatched propensity-score-adjusted model, and overlap-weighted covariate-balance diagnostics. All analyses are exploratory; p values are descriptive and no adjustment for multiplicity was performed.

Ethics and Oversight

The protocol was approved by the China Medical University Hospital Research Ethics Committee. All data were retrospectively collected and anonymised; informed consent was waived. No U.S. FDA-regulated drug, device, IND, or IDE is involved. Because this is a retrospective chart-review study, a formal data-monitoring committee was not required.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 2025.
  • Patients who received either direct three-vessel antegrade cerebral perfusion (MACP) or unilateral right axillary antegrade cerebral perfusion (uACP).

Exclusion criteria

  • 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.

Treatment and study plan

Direct Three-Vessel Antegrade Cerebral Perfusion (MACP)

Procedure

Direct antegrade cerebral perfusion through balloon-tipped catheters inserted into the brachiocephalic, left common carotid, and left subclavian arteries during emergency total arch replacement.

Unilateral Right Axillary Antegrade Cerebral Perfusion (uACP)

Procedure

Unilateral antegrade cerebral perfusion delivered through right axillary artery cannulation during emergency total arch replacement.

Primary outcomes

  1. Postoperative Stroke

    Time frame: 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.

Secondary outcomes

  1. In-Hospital Mortality

    Time frame: During the index admission, up to hospital discharge.

    Death before discharge during the index admission.

  2. Hospital Length of Stay

    Time frame: From surgery to hospital discharge.

    Length of hospital stay, measured in days from surgery to hospital discharge.

  3. ICU Length of Stay

    Time frame: From postoperative ICU admission to ICU discharge during the index admission.

    Length of postoperative intensive care unit stay, measured in days from postoperative ICU admission to ICU discharge.

  4. Mechanical Ventilation Duration

    Time frame: During the index admission, up to liberation from invasive ventilation.

    Mechanical-ventilation duration was measured from postoperative intensive-care unit admission to liberation from invasive ventilation.

  5. Postoperative Acute Kidney Injury (AKI)

    Time frame: Within 7 postoperative days.

    Acute kidney injury was defined as KDIGO stage 1 or higher within 7 postoperative days, based on serum creatinine criteria.

  6. Dialysis Requirement

    Time frame: During the index admission, up to hospital discharge.

    Requirement for new postoperative renal replacement therapy during the index admission.

  7. Number of Participants Requiring Re-operation for Bleeding

    Time frame: During the index admission, up to hospital discharge.

    Return to the operating room for postoperative bleeding or haematoma evacuation during the index admission.

  8. Number of Participants with Sepsis (Sepsis-3)

    Time frame: During the index admission, up to hospital discharge.

    Sepsis during the index admission, defined according to Sepsis-3 criteria as suspected or documented infection with organ dysfunction.

  9. Number of Participants with Postoperative Atrial Fibrillation

    Time frame: During the index admission, up to hospital discharge.

    Postoperative atrial fibrillation was defined as new-onset atrial fibrillation documented after surgery during the index admission.

  10. Tracheostomy

    Time frame: During the index admission, up to hospital discharge.

    Placement of a tracheostomy after surgery during the index admission.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

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)

Acronym: MACP

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2025
Registry last updated
Jul 1, 2026

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

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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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