Arch-clamping with mild hypothermia for acute Type A aortic dissection.

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

This study will test whether using arch-clamping under mild hypothermia during total arch replacement with frozen elephant trunk reduces major complications in adults with acute Type A aortic dissection.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 306 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07150559 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, open-label, three-arm parallel trial enrolling 306 patients with acute Type A aortic dissection across seven hospitals in China. All participants undergo total aortic arch replacement with frozen elephant trunk and are randomized 1:1:1 to arch-clamping under mild hypothermia, arch-clamping under moderate hypothermia, or Sun's procedure using bilateral antegrade cerebral perfusion under moderate hypothermic circulatory arrest. The trial compares the incidence of major adverse events (death, renal replacement therapy, stroke, paraplegia) and procedural measures including circulatory arrest time, cardiopulmonary bypass time, mechanical ventilation duration, and ICU length of stay. Participants are followed for one year to determine the safety and validity of the mild hypothermic arch-clamping technique.

Who should consider this trial

Good fit: Adults aged 18–70 with CTA-confirmed acute Type A aortic dissection, weighing 50–120 kg, presenting within 14 days of symptom onset and eligible for total aortic arch replacement who can provide informed consent are ideal candidates.

Not a fit: Patients with chronic renal failure, severe liver disease, severe preoperative neurological compromise or intubation, inflammatory or infectious aortitis, prior cardiac/aortic surgery, or other excluded conditions are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, this approach could lower rates of death, stroke, and renal failure and shorten ICU and ventilation times after surgery for acute Type A aortic dissection.

How similar studies have performed: Cerebral protection strategies such as bilateral antegrade cerebral perfusion and Sun's procedure have supportive clinical experience, but randomized data specifically testing arch-clamping under mild hypothermia are limited.

Eligibility criteria

Inclusion Criteria:

1. Aortic CTA confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;
2. Adult patients (18-70 years) weighing 50-120 kg;
3. Time interval between the onset of symptoms and operation is less than 14 days;
4. Indications for total aortic arch replacement are available;
5. Signed informed consent and availability for follow-up.

Exclusion Criteria:

1. History of chronic renal failure, hepatocirrhosis, and hepatic insufficiency;
2. Severe gastrointestinal complications of non-aortic dissection, such as mesenteric ischemia, gastrointestinal bleeding, hepatopancreaticobiliary dysfunction, and intestinal obstruction;
3. History of severe cerebral infarction (with cerebral infarction sequels);
4. Preoperative intubation or unconsciousness;
5. Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;
6. History of infectious aortic diseases;
7. History of cardiac and aortic surgery;
8. History of malignancy or previous radiotherapy;
9. Pregnant or feeding women, or anyone planning to reproduce during the test period;
10. Without an informed consent signature;
11. Participating in any other clinical trial;
12. Having other causes not eligible for operation.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Su-Wei Chen, Doctor

Conditions Acute Type A Aortic Dissection; Hypothermia; Total Aortic Arch Replacement; Frozen Elephant Trunk; Bilateral Antegrade Cerebral Perfusion