Effectiveness of Bilateral Modified Catheter Antegrade Cerebral Perfusion in Acute Type A Aortic Dissection Surgery

NCT07043777 | Completed

• 1 other identifier: CMUH114-REC1-089
• Study Type: observational
• Target: 274
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center retrospective cohort study examines whether a Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) technique improves early clinical outcomes in adults undergoing emergency repair of acute Type A aortic dissection (ATAAD). Electronic medical records at China Medical University Hospital (CMUH) will be reviewed for all ATAAD operations performed between 1 January 2021 and 30 April 2025. Patients treated with Modified bACP will be compared with those managed by conventional perfusion strategies. The primary outcome is in-hospital stroke. Secondary outcomes include postoperative neurologic deficit, in-hospital mortality, 30-day mortality, hospital and ICU length of stay, mechanical-ventilation duration, need for tracheostomy, acute kidney injury, dialysis requirement, reoperation for bleeding, sepsis, atrial fibrillation, and myocardial infarction. Findings will clarify the efficacy and safety of Modified bACP and may inform future cerebral-protection protocols in aortic surgery.

Conditions

Acute Type A Aortic Dissection

Keywords

Bilateral Modified Catheter Antegrade Cerebral Perfusion; Modified bACP; Cerebral Protection; Neurologic Complications; Retrospective Cohort; Cardiovascular Surgery; China Medical University Hospital; Ascending Aortic Graft Replacement

Outcome Measures

Primary Outcomes (1)

• Postoperative Stroke

  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.

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

Secondary Outcomes (11)

• Postoperative Neurological Deficit

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

• 30-Day Mortality

  Assessed at 30 days post-surgery

• Hospital Length of Stay

  From end of surgery to discharge (max 30 days)

• 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)

Study Arms (2)

Modified bACP Group

Patients who underwent acute type A aortic dissection repair between 1 Jan 2021 and 30 Apr 2025 using the bilateral modified catheter antegrade cerebral perfusion (Modified bACP) technique.

Procedure: Modified Catheter Antegrade Cerebral Perfusion (Modified bACP)

Conventional Perfusion Group

Patients who underwent acute type A aortic dissection repair in the same period using the conventional cerebral perfusion strategy (e.g., standard bilateral ACP or surgeon-preferred method). Serves as the comparison cohort.

Procedure: Conventional Brain Perfusion

Interventions

Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) PROCEDURE

Bilateral modified catheter antegrade cerebral perfusion technique applied during acute type A aortic dissection repair; avoids additional right-axillary incision while providing continuous cerebral flow.

Modified bACP Group

Conventional Brain Perfusion PROCEDURE

Conventional cerebral perfusion strategy (e.g., standard bilateral antegrade cerebral perfusion) used during arch repair according to surgeon preference.

Conventional Perfusion Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients treated for acute Stanford Type A aortic dissection with open surgical repair at a single tertiary medical center (China Medical University Hospital, Taichung, Taiwan) between 2021-01-01 and 2025-04-30. The population comprises two retrospectively identified cohorts based on intra-operative cerebral-perfusion strategy (modified bilateral catheter ACP vs conventional perfusion).

You may qualify if:

• Adults (≥ 18 years) who underwent acute Type A aortic dissection repair at China Medical University Hospital between 01 Jan 2021 and 30 Apr 2025.

You may not qualify if:

• Documented preoperative stroke or severe neurological deficit prior to surgery.
• Pregnant patients.
• Patients \< 18 years old.
• Insufficient or missing medical records that preclude data analysis or verification of outcomes.

Sponsors & Collaborators

• China Medical University Hospital: lead

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: 36983272 BACKGROUND

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 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)