Remote ischemic preconditioning during emergency Type A aortic dissection surgery

Evaluation of the Organ-Protective Effects of Remote Ischemic Preconditioning in Patients Undergoing Surgery for Acute Type A Aortic Dissection: A Multicenter, Prospective, Double-Blind, Randomized Controlled Trial

This will test whether brief cycles of limb cuff inflation during emergency Type A aortic dissection surgery can protect organs and reduce serious complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1296 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fujian Medical University (Academic / other)
• Locations: 3 sites (Fuzhou, Fujian and 2 other locations)
• Trial ID: NCT07383909 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older with acute Type A aortic dissection requiring emergency surgery (symptom onset <14 days) who can provide informed consent or have a legal representative to consent.

Not a fit: Patients with limb ischemia at the planned intervention site, prior open cardiac or thoracic aortic surgery, severe preoperative organ failure, recent myocardial infarction or stroke, or end-stage renal or liver disease are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, RIPC could reduce perioperative organ injury and major complications, improving survival and recovery after emergency ATAAD surgery.

How similar studies have performed: Remote ischemic conditioning has produced mixed results in elective cardiac surgery—some studies reported reduced biochemical markers of injury but inconsistent clinical outcome benefits, and its application in emergency ATAAD surgery is largely untested.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years, with no restriction on sex;
2. Diagnosis of acute Type A aortic dissection requiring emergency surgery (symptom onset \<14 days);
3. Ability to understand the study objectives, voluntary provision of written informed consent by the patient or a legally authorized representative, and willingness to comply with follow-up.

Exclusion Criteria:

1. Traumatic or iatrogenic aortic dissection;
2. Previous open cardiac or thoracic aortic surgery;
3. Severe preoperative dysfunction of vital organs, such as persistent deep coma, abdominal compartment syndrome, or circulatory failure;
4. Severe comorbidities, including myocardial infarction within the past 7 days, stroke within the past 2 months; end-stage renal disease (eGFR \<30 ml/min/1.73 m²); end-stage liver disease (total bilirubin \>342 μmol/L or INR \>2.0);
5. Evidence of ischemia in the limb planned for intervention, such as decreased skin temperature, pain, pallor, with or without sensory disturbance, paralysis, or diminished/absent pulses; or severe deformity or prior arteriovenous surgery at the intervention site;
6. Peripheral arterial disease involving the limbs, Raynaud phenomenon, active phlebitis, or a history of deep vein thrombosis of the lower extremities;
7. Current use of sulfonylurea oral hypoglycemic agents or nicorandil;
8. Life expectancy \<1 year (e.g., advanced malignancy);
9. Participation in another clinical trial without having reached its primary endpoint;
10. Pregnancy or lactation; immunodeficiency (e.g., HIV positivity, history of organ transplantation); known bleeding disorders, coagulation abnormalities, or sickle cell anemia; active or uncontrolled infection;
11. Other severe physical or psychiatric disorders, or laboratory abnormalities, which in the investigator's judgment may increase risk or interfere with study outcomes, rendering the patient unsuitable for enrollment.

Where this trial is running

Fuzhou, Fujian and 2 other locations

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
• Xiamen Cardiovascular Hospital, Xiamen University — Xiamen, Fujian, China (Not_yet_recruiting)
• The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Liang-wan Chen, M.D Ph.D

Conditions Aortic Dissection Type A; Remote Ischaemic Conditioning; ischemia reperfusion injury; emergency surgery; major adverse outcomes