Arch-Clamping Technique Under Mild Hypothermia in Treating With Acute Type A Aortic Dissection: Study Protocol for a Multicenter, Three-arm, Open-label, Randomized, Parallel-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Major adverse events
研究概览
简要总结
The study is a multicenter, three-arm, open-label, randomized, parallel-controlled trial, which plans to enroll 306 participants diagnosed with acute type A aortic dissection (ATAAD) from 7 hospitals in China. All patients receive total arch replacement (TAR) combined with frozen elephant trunk (FET) implantation and are randomized to Group 1 (arch-clamping technique under mild hypothermia), Group 2 (arch-clamping technique under moderate hypothermia) and Group 3 (Sun's procedure using bilateral antegrade cerebral perfusion) in the ratio of 1:1:1. After a 1-year follow-up, the validity and safety of the mild hypothermic arch-clamping technique for ATAAD was evaluated via the incidence of major adverse events including death, renal replacement therapy, stroke, and paraplegia, as well as times of circulatory arrest, cardiopulmonary bypass, and mechanical ventilation, and length of ICU stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aortic CTA confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;
- •Adult patients (18-70 years) weighing 50-120 kg;
- •Time interval between the onset of symptoms and operation is less than 14 days;
- •Indications for total aortic arch replacement are available;
- •Signed informed consent and availability for follow-up.
排除标准
- •History of chronic renal failure, hepatocirrhosis, and hepatic insufficiency;
- •Severe gastrointestinal complications of non-aortic dissection, such as mesenteric ischemia, gastrointestinal bleeding, hepatopancreaticobiliary dysfunction, and intestinal obstruction;
- •History of severe cerebral infarction (with cerebral infarction sequels);
- •Preoperative intubation or unconsciousness;
- •Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;
- •History of infectious aortic diseases;
- •History of cardiac and aortic surgery;
- •History of malignancy or previous radiotherapy;
- •Pregnant or feeding women, or anyone planning to reproduce during the test period;
- •Without an informed consent signature;
- •Participating in any other clinical trial;
- •Having other causes not eligible for operation.
研究组 & 干预措施
Arch-clamping under mild hypothermia
TAR + FET procedure is performed using arch-clamping technique under mild hypothermia.
干预措施: Arch-Clamping Technique under Mild Hypothermia (Procedure)
Arch-clamping under moderate hypothermia
TAR + FET procedure is performed using arch-clamping technique under moderate hypothermia.
干预措施: Arch-Clamping Technique under Moderate Hypothermia (Procedure)
Sun's procedure using bACP
Total arch replacement and frozen elephant trunk implantation with moderate hypothermic circulatory arrest.
干预措施: Total Arch Replacement combined Frozen Elephant Trunk Implantation using Bilateral Antegrade Cerebral Perfusion under Moderate Hypothermic Circulatory Arrest (Procedure)
结局指标
主要结局
Major adverse events
时间窗: Thirty days and 12 months after the operation
Major adverse events include death, renal replacement therapy, stroke, and paraplegia
次要结局
- Mechanical ventilation time(Discharge / 30 days after operation)
- The length of ICU stay(Discharge / 30 days after operation)
- Circulatory arrest time(During surgery)
- Cardiopulmonary bypass time(During surgery)
研究者
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