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

A Retrospective Cohort Study Evaluating the Efficacy of Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) in Acute Type A Aortic Dissection Surgery

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06943716
Enrollment
273
Registered
2025-04-24
Start date
2021-01-01
Completion date
2025-04-11
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Type A Aortic Dissection

Keywords

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

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.

Interventions

PROCEDUREModified 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.

PROCEDUREConventional 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.

Sponsors

China Medical University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
StrokeThrough hospital discharge (on average about 14 days post-surgery)New-onset cerebrovascular accident or imaging-confirmed stroke during hospitalization.

Secondary

MeasureTime frameDescription
30-day MortalityAssessed at 30 days post-surgeryAll-cause mortality occurring within 30 days after the surgical procedure.
Hospital Stay (day)From end of surgery to hospital discharge (up to 21 days).Total number of days from the operation date to the date of hospital discharge.
ICU Stay (day)From end of surgery to ICU discharge (up to 10 days).Length of stay in the intensive care unit after surgery.
Mechanical Ventilation (hour)From end of surgery until extubation (up to 72 hours).Duration of mechanical ventilation in hours.
Acute Kidney Injury (AKI)During the index hospitalization (on average about 10-14 days post-surgery)Acute kidney injury defined by changes in serum creatinine or urine output (e.g., KDIGO criteria).
Postoperative Neurological DeficitThrough hospital discharge (on average about 14 days post-surgery)Any persistent neurological deficit (e.g., motor/sensory deficits) identified after surgery.
Reoperation for BleedingDuring the index hospitalization (on average about 72 hours post-surgery)Number of patients requiring a return to the operating room for bleeding control or hematoma.
SepsisDuring the index hospitalization (on average within 7 days post-surgery)Incidence of sepsis as defined by current guidelines (e.g., Sepsis-3), typically requiring positive cultures and organ dysfunction.
Atrial Fibrillation (Af)During the index hospitalization (on average within 7 days post-surgery)New-onset atrial fibrillation or documented arrhythmia episodes requiring clinical management.
Myocardial InfarctionDuring the index hospitalization (on average about 10-14 days post-surgery)Clinically confirmed myocardial infarction based on ECG changes, cardiac enzymes, and clinical symptoms.
Dialysis RequirementDuring the index hospitalization (on average about 10-14 days post-surgery)Proportion of patients requiring renal replacement therapy (dialysis) postoperatively.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026