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

NCT ID: NCT06943716

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 273 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-04-11

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).

Detailed Description

Background and Rationale Acute Type A aortic dissection (ATAAD) is a life-threatening condition requiring urgent surgical repair. Prolonged circulatory arrest increases the risk of neurological complications. Bilateral antegrade cerebral perfusion (bACP) has shown potential to reduce ischemic injury. However, conventional bACP requires additional surgical access. This study examines a Modified bACP approach that may reduce surgical trauma while maintaining adequate cerebral perfusion.

Objectives This retrospective cohort study evaluates whether Modified bACP improves postoperative outcomes compared to conventional perfusion strategies in ATAAD surgery at China Medical University Hospital (2021/1/1-2024/10/31).

Methods We will collect and analyze medical records of adult patients who underwent ATAAD repair, comparing those who received Modified bACP to those managed with conventional perfusion.

Outcome Measures

Primary Outcomes:

In-hospital mortality 30-day mortality

Secondary Outcomes:

Hospital length of stay (day) ICU length of stay (day) Mechanical ventilation duration (hours) Need for tracheostomy Stroke Postoperative neurological deficit Paraplegia Coma Atrial fibrillation (Af) Myocardial infarction Acute kidney injury (AKI) Dialysis requirement Reoperation for bleeding Sepsis Significance This study aims to provide comprehensive data on the safety and efficacy of Modified bACP in ATAAD surgery, potentially improving neurological protection and reducing other major complications and resource utilization. The findings may guide clinical practice and inform future protocol developments.

Conditions

Acute Type A Aortic Dissection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Modified Catheter Antegrade Cerebral Perfusion (Modified bACP)

Intervention Type: 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.

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.

Conventional Brain Perfusion

Intervention Type: 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.

Interventions

Modified Catheter Antegrade Cerebral Perfusion (Modified bACP)

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.

Intervention Type: PROCEDURE

Conventional Brain Perfusion

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

En-Bo Wu, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

References

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.

Reference Type: RESULT

PMID: 36983272 (View on PubMed)

Other Identifiers

CMUH113-REC1-183

Identifier Type: OTHER

Identifier Source: secondary_id

CMUH113-REC1-183

Identifier Type: -

Identifier Source: org_study_id