CompaRison of FEmorofemoral Bypass and Left-Heart ByPass Techniques in Open Thoracoabdominal AortIc Aneurysm Repair

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

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.

Inclusion Criteria:

1. Computed tomography angiography (CTA) confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;
2. Adult patients (≥18 years old);
3. Indications for TAAAR are available and requiring cardiopulmonary bypass;
4. Signed informed consent and availability for follow-up.

Exclusion Criteria:

1. History of chronic renal failure, chronic heart failure, Coronary heart disease with established surgical indications, hepatocirrhosis, and hepatic insufficiency;
2. History of severe cerebral infarction (with cerebral infarction sequels);
3. Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;
4. History of infectious aortic diseases;
5. History of malignancy or previous radiotherapy;
6. Pregnant or feeding women, or anyone planning to reproduce during the test period;
7. Participating in any other clinical trial;
8. Having other causes not eligible for operation.