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

Official title

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

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.

Interventions

• Procedure Thoracoabdominal aortic aneurysm repair under fCPB
  This procedure is performed under fCPB via femoral artery and vein, inferior vena cava outside the pericardial cavity is alternative choice. Two clamps were used to occlude the distal aortic arch beyond the left subclavian artery and the proximal descending aorta at the same time. A triple occlusion technique could also be adopted when the aneurysm neck was located high. The proximal abdominal aorta was clamped at the diaphragmatic level after the proximal anastomosis was completed, then interco
• Procedure Thoracoabdominal aortic aneurysm repair under LHB
  This procedure is performed under LHB via the left inferior pulmonary vein and femoral artery. Two clamps were used to occlude the distal aortic arch beyond the left subclavian artery and the proximal descending aorta at the same time. A triple occlusion technique could also be adopted when the aneurysm neck was located high. The proximal abdominal aorta was clamped at the diaphragmatic level after the proximal anastomosis was completed, then intercostal artery reconstruction was performed using

Primary outcome measures

• Major adverse events [Time frame: Thirty days and 12 months after the operation]

Secondary outcome measures (3)

• Blood Product Transfusion Volume [Time frame: Surgical day and postoperative 1 to 3 days]
• Duration of Mechanical Ventilation [Time frame: Surgical day, postoperative 1 to 3 days, and discharge day / postoperative 30 days.]
• Early Mortality [Time frame: Postoperative 6 to 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Anzhen Hospital — Beijing

Identifiers

NCT: NCT07518251 · 2023ZD0504403

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗