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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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

Первичные конечные точки

• Major adverse events [Срок оценки: Thirty days and 12 months after the operation]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Anzhen Hospital — Пекин

Идентификаторы

NCT: NCT07518251 · 2023ZD0504403

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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