Clinical trial NCT06943716: Efficacy of Bilateral Modified Catheter Antegrade Cerebral Perfusion in Acute Type A Aortic Dissection Surgery
Official title: A Retrospective Cohort Study Evaluating the Efficacy of Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) in Acute Type A Aortic Dissection Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Type A Aortic Dissection
Keywords: Bilateral Catheter Antegrade Cerebral Perfusion
Acute Type A Aortic Dissection
Neurological Complications
Modified bACP
Retrospective Cohort
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Stroke
timeFrame: Through hospital discharge (on average about 14 days post-surgery)
Secondary outcomes:
measure: Postoperative Neurological Deficit
timeFrame: Through hospital discharge (on average about 14 days post-surgery)
measure: 30-day Mortality
timeFrame: Assessed at 30 days post-surgery
measure: Hospital Stay (day)
timeFrame: From end of surgery to hospital discharge (up to 21 days).
measure: ICU Stay (day)
timeFrame: From end of surgery to ICU discharge (up to 10 days).
measure: Mechanical Ventilation (hour)
timeFrame: From end of surgery until extubation (up to 72 hours).
measure: Acute Kidney Injury (AKI)
timeFrame: During the index hospitalization (on average about 10-14 days post-surgery)
measure: Dialysis Requirement
timeFrame: During the index hospitalization (on average about 10-14 days post-surgery)
measure: Reoperation for Bleeding
timeFrame: During the index hospitalization (on average about 72 hours post-surgery)
measure: Sepsis
timeFrame: During the index hospitalization (on average within 7 days post-surgery)
measure: Atrial Fibrillation (Af)
timeFrame: During the index hospitalization (on average within 7 days post-surgery)
measure: Myocardial Infarction
timeFrame: During the index hospitalization (on average about 10-14 days post-surgery)
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: Department of Anesthesiology, China Medical University Hospital, China Medical University, Taichung City 404, Taiwan
name: En-Bo Wu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.