Comparison of Femorofemoral Bypass and Left-Heart Bypass Techniques in Open Thoracoabdominal Aortic Aneurysm Repair: A Study Protocol for Multicenter, Two-Arm, Open-Label, Randomized, ParalleI-Controlled Non-Inferiority Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Beijing Anzhen Hospital
- Enrollment
- 236
- Locations
- 1
- Primary Endpoint
- Major adverse events
Overview
Brief Summary
The study is a multicenter, two-arm, open-label, randomized, parallel-controlled trial, which plans to enroll 236 participants diagnosed with TAAA from 4 hospitals in China. All patients receive TAAAR procedure and are randomized to control group (LHB) and experimental group (fCPB) in the ratio of 1:1. After a 1-year follow-up, the validity and safety of the different cardiopulmonary bypass for TAAAR is evaluated via the incidence of major adverse events including surgical mortality, RRT, stroke, and SCI, as well as intraoperative blood product transfusion volume, mechanical ventilation, and early mortality.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Computed tomography angiography (CTA) confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;
- •Adult patients (≥18 years old);
- •Indications for TAAAR are available and requiring cardiopulmonary bypass;
- •Signed informed consent and availability for follow-up.
Exclusion Criteria
- •History of chronic renal failure, chronic heart failure, Coronary heart disease with established surgical indications, hepatocirrhosis, and hepatic insufficiency;
- •History of severe cerebral infarction (with cerebral infarction sequels);
- •Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;
- •History of infectious aortic diseases;
- •History of malignancy or previous radiotherapy;
- •Pregnant or feeding women, or anyone planning to reproduce during the test period;
- •Participating in any other clinical trial;
- •Having other causes not eligible for operation.
Arms & Interventions
femoro-femoral cardiopulmonary bypass
Thoracoabdominal aortic aneurysm repair is performed under fCPB.
Intervention: Thoracoabdominal aortic aneurysm repair under fCPB (Procedure)
left heart bypass
Thoracoabdominal aortic aneurysm repair is performed under LHB.
Intervention: Thoracoabdominal aortic aneurysm repair under LHB (Procedure)
Outcomes
Primary Outcomes
Major adverse events
Time Frame: Thirty days and 12 months after the operation
Major adverse events include surgical mortality, renal replacement treatment, stroke, and spinal cord injury.
Secondary Outcomes
- Blood Product Transfusion Volume(Surgical day and postoperative 1 to 3 days)
- Duration of Mechanical Ventilation(Surgical day, postoperative 1 to 3 days, and discharge day / postoperative 30 days.)
- Early Mortality(Postoperative 6 to 12 months)
Investigators
Junming Zhu
Vice Chairman, Aortic Surgery Committee of Chinese Association of Cardiovascular Surgeons; President, Beijing Society for Thoracic and Cardiovascular Surgery; Director, Center for Aortic Surgery, Beijing Anzhen Hospital
Beijing Anzhen Hospital