NCT07043777

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

4.3 years

First QC Date

June 20, 2025

Last Update Submit

June 28, 2026

Conditions

Keywords

Cerebral ProtectionNeurologic ComplicationsRetrospective CohortCardiovascular SurgeryChina Medical University HospitalDirect Three-Vessel Antegrade Cerebral PerfusionModified Antegrade Cerebral PerfusionUnilateral Antegrade Cerebral PerfusionTotal Arch ReplacementAcute Type A Aortic DissectionPostoperative Stroke

Outcome Measures

Primary Outcomes (1)

  • Postoperative Stroke

    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.

    During the index admission, up to hospital discharge.

Secondary Outcomes (10)

  • 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.

  • +5 more secondary outcomes

Study Arms (2)

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.

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

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.

Procedure: Unilateral Right Axillary Antegrade Cerebral Perfusion (uACP)

Interventions

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

Unilateral Right Axillary ACP (uACP) Group

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

Direct Three-Vessel ACP (MACP) Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive adult patients who underwent emergency total arch replacement for acute type A aortic dissection at China Medical University Hospital, Taichung, Taiwan, between 1 January 2021 and 30 April 2025. The analytic population was restricted to patients who received either direct three-vessel antegrade cerebral perfusion (MACP) or unilateral right axillary antegrade cerebral perfusion (uACP).

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Related Publications (1)

  • Pitts L, Kofler M, Montagner M, Heck R, Iske J, Buz S, Kurz SD, Starck C, Falk V, Kempfert J. Cerebral Protection Strategies and Stroke in Surgery for Acute Type A Aortic Dissection. J Clin Med. 2023 Mar 15;12(6):2271. doi: 10.3390/jcm12062271.

    PMID: 36983272BACKGROUND

Study Officials

  • En-Bo Wu, M.D.

    Department of Anesthesiology, China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2025

First Posted

June 29, 2025

Study Start

January 1, 2021

Primary Completion

April 30, 2025

Study Completion

June 1, 2025

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared publicly because the dataset was derived from retrospective electronic health records and contains potentially sensitive clinical information. Any external access, if considered, would require separate institutional review and ethics approval.

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