Comparing Mild and Moderate Hypothermia Arch-Clamping Techniques for Acute Type A Aortic Dissection Treatment A Multicenter Randomized Trial with Total Arch Replacement and Frozen Elephant Trunk Procedures

What this Trial Is About

Researchers are conducting a multicenter, randomized clinical trial to evaluate different surgical techniques for treating Acute Type A Aortic Dissection ATAAD. The study aims to compare the safety and effectiveness of arch-clamping techniques performed under mild and moderate hypothermia against Suns procedure using bilateral antegrade cerebral perfusion. The trial involves 306 adult participants diagnosed with ATAAD from multiple hospitals in China to better understand major adverse events and recovery outcomes after surgery. Participants undergo total arch replacement combined with frozen elephant trunk implantation, then are randomly assigned to one of three groups arch-clamping under mild hypothermia, arch-clamping under moderate hypothermia, or Suns procedure under moderate hypothermic circulatory arrest with bilateral antegrade cerebral perfusion. Each surgical method involves specific steps to restore blood flow and reconstruct arteries using grafts during the operation. During the study, participants are closely monitored for one year after surgery. Researchers assess major adverse events such as death, need for renal replacement therapy, stroke, and paraplegia. They also measure surgical factors including circulatory arrest time, cardiopulmonary bypass time, mechanical ventilation duration, and length of ICU stay. Follow-up evaluations help determine the safety and validity of the mild hypothermic arch-clamping technique compared to the others.

Arch-Clamping Technique Under Mild Hypothermia in Treating With Acute Type A Aortic Dissection