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

NCT06943716 | Terminated

• 1 other identifier: CMUH113-REC1-183
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective cohort study aims to evaluate the efficacy of a Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) technique in acute Type A aortic dissection surgery. Medical records from January 1, 2021, through October 31, 2024, at China Medical University Hospital will be reviewed. The primary outcomes include in-hospital mortality and stroke rate, while secondary outcomes include ICU/hospital stay, mechanical ventilation duration, and other postoperative complications (e.g., acute kidney injury, sepsis, myocardial infarction).

Conditions

Acute Type A Aortic Dissection

Keywords

Bilateral Catheter Antegrade Cerebral Perfusion; Acute Type A Aortic Dissection; Neurological Complications; Modified bACP; Retrospective Cohort

Outcome Measures

Primary Outcomes (1)

• Stroke

  New-onset cerebrovascular accident or imaging-confirmed stroke during hospitalization.

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

Secondary Outcomes (11)

• Postoperative Neurological Deficit

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

• 30-day Mortality

  Assessed at 30 days post-surgery

• Hospital Stay (day)

  From end of surgery to hospital discharge (up to 21 days).

• ICU Stay (day)

  From end of surgery to ICU discharge (up to 10 days).

• Mechanical Ventilation (hour)

  From end of surgery until extubation (up to 72 hours).

Study Arms (2)

Modified bACP Group

Patients who underwent acute Type A aortic dissection repair using the Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) technique. This observational group received the modified perfusion strategy aimed at reducing surgical trauma and enhancing cerebral protection.

Procedure: Modified Catheter Antegrade Cerebral Perfusion (Modified bACP)

Conventional Perfusion Group

Patients who underwent acute Type A aortic dissection repair using the conventional brain perfusion technique (e.g., standard bilateral antegrade cerebral perfusion). This group serves as the comparison cohort for evaluating the effects of the modified technique.

Procedure: Conventional Brain Perfusion

Interventions

Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) PROCEDURE

A modified bilateral catheter antegrade cerebral perfusion technique used for acute Type A aortic dissection repair. This approach aims to reduce surgical trauma by avoiding additional right axillary access while maintaining stable cerebral perfusion.

Modified bACP Group

Conventional Brain Perfusion PROCEDURE

Patients receiving the conventional perfusion strategy for aortic arch surgery, which may include standard bilateral ACP based on the surgeon's preference and the patient's condition.

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

Adult patients diagnosed with acute Type A aortic dissection who underwent surgical repair at China Medical University Hospital. The population includes individuals receiving either Modified bACP or conventional perfusion during the specified period.

You may qualify if:

• Adults (≥ 18 years old) who underwent acute Type A aortic dissection repair at China Medical University Hospital between January 1, 2021, and October 31, 2024.

You may not qualify if:

• Preexisting severe neurological impairment (e.g., stroke or other major neurological deficits before surgery).
• Age \< 18 years.
• Pregnant patients.
• Insufficient or missing medical records preventing data analysis.

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 RESULT

Study Officials

• En-Bo Wu, M.D.

  Department of Anesthesiology, China Medical University Hospital, China Medical University, Taichung City 404, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 24, 2025
• Study Start: January 1, 2021
• Primary Completion: October 31, 2024
• Study Completion: April 11, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)