Remote ischemic preconditioning during emergency Type A aortic dissection surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, double-blind, randomized, sham-controlled trial enrolls adults undergoing emergency surgery for acute Type A aortic dissection. After induction of general anesthesia, participants receive either remote ischemic preconditioning (alternating 5-minute cuff inflations and 5-minute deflations on the arm and thigh for four cycles) or a sham procedure. The trial tracks a composite of major perioperative adverse outcomes and safety until hospital discharge (or up to 30 days), with follow-up visits at 3 months, 1 year, and then yearly for up to 5 years. Outcomes will compare incidence of severe complications, organ failure, and mortality between the RIPC and control groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years;
2. Acute type A aortic dissection requiring emergency surgery within 14 days of symptom onset;
3. Written informed consent provided by the participant or a legally authorized representative;
4. Willingness to comply with study follow-up.

Exclusion Criteria:

1. Traumatic or iatrogenic aortic dissection;
2. Previous open cardiac or thoracic aortic surgery;
3. Persistent deep coma (Glasgow Coma Scale score ≤8), abdominal compartment syndrome, preoperative mechanical circulatory support, or norepinephrine-equivalent dose \>0.1 μg/kg/min;
4. Estimated glomerular filtration rate \<30 mL/min/1.73 m², total bilirubin \>342 μmol/L, or international normalized ratio \>2.0;
5. Evidence of ischemia in the limb planned for intervention, including decreased skin temperature, pain, or pallor, with or without sensory disturbance, paralysis, or diminished or absent peripheral pulses; severe deformity of the limb; or a history of arterial or venous surgery at the planned intervention site;
6. Peripheral arterial disease involving the limbs, Raynaud phenomenon, active phlebitis, or a history of lower-extremity deep vein thrombosis;
7. Current use of sulfonylureas or nicorandil;
8. Expected survival \<1 year;
9. Concurrent participation in another clinical trial that has not yet reached its primary endpoint;
10. Pregnancy or breastfeeding;
11. Immunodeficiency, a known bleeding or coagulation disorder, sickle cell anemia, or active or uncontrolled infection;
12. Any other condition considered unsuitable for enrollment by the investigator

Where it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• Xiamen Cardiovascular Hospital, Xiamen University
  Xiamen, Fujian, China Recruiting
• The First Affiliated Hospital of Dalian Medical University
  Dalian, Liaoning, China Recruiting
• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Not yet recruiting
• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Not yet recruiting
• The First Affiliated Hospital of Sun Yat-Sen University
  Guangzhou, Guangdong, China Not yet recruiting

Study contacts

• Study coordinator: Liang-wan Chen, M.D Ph.D
• Email: chenliangwan@fjmu.edu.cn
• Phone: +8613358255333

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.