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 Trail
The study is a multicenter, three-arm, open-label, randomized, parallel-controlled trail, 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 stay.
• 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.