Efficacy of Bilateral Modified Catheter Antegrade Cerebral Perfusion in Acute Type A Aortic Dissection Surgery
- Conditions
- Acute Type A Aortic Dissection
- Registration Number
- NCT06943716
- Lead Sponsor
- China Medical University Hospital
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 273
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stroke Through hospital discharge (on average about 14 days post-surgery) New-onset cerebrovascular accident or imaging-confirmed stroke during hospitalization.
- Secondary Outcome Measures
Name Time Method Postoperative Neurological Deficit Through hospital discharge (on average about 14 days post-surgery) Any persistent neurological deficit (e.g., motor/sensory deficits) identified after surgery.
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).
Dialysis Requirement During the index hospitalization (on average about 10-14 days post-surgery) Proportion of patients requiring renal replacement therapy (dialysis) postoperatively.
Reoperation for Bleeding During 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.
Sepsis During 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 Infarction During the index hospitalization (on average about 10-14 days post-surgery) Clinically confirmed myocardial infarction based on ECG changes, cardiac enzymes, and clinical symptoms.
30-day Mortality Assessed at 30 days post-surgery All-cause mortality occurring within 30 days after the surgical procedure.
Trial Locations
- Locations (1)
China Medical University Hospital
🇨🇳Taichung City, Taiwan