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RECRUITING Not applicable ClinicalTrials.gov

Remote Ischemic Preconditioning for Aute Type A Aortic Dissection Surgery

Sponsor: Fujian Medical University • ClinicalTrials.gov ID: NCT07383909

Registry updated: 2026-09-16
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Description

The goal of this clinical trial is to learn if a technique called remote ischemic preconditioning (RIPC) helps protect organs during emergency surgery for acute type A aortic dissection (ATAAD). The main questions it aims to answer are: Does RIPC reduce the risk of major complications after surgery, such as heart, brain, or kidney problems? Is RIPC safe to use during emergency ATAAD surgery? Researchers will compare the RIPC group to a control group (who will receive a placebo) to see if RIPC can reduce complications after surgery. Participants will: Receive either RIPC or a sham intervention during their surgery. Be monitored for up to 30 days after surgery for complications. Have follow-up visits at 3 months, 1 year, and then yearly for up to 5 years to track their recovery.

Interventions

  • Remote ischemic preconditioning (RIPC) (Procedure)
    This intervention is a non-invasive organ-protective procedure. After induction of general anesthesia, remote ischemic preconditioning (RIPC) will be applied to the upper arm and thigh. Both the upper arm and thigh will each undergo four ischemia-reperfusion cycles. Each cycle consists of 5 minutes of cuff inflation at 200 mmHg-or at least 15 mmHg above the systolic blood pressure if the systolic blood pressure exceeds 185 mmHg-to induce ischemia, followed by 5 minutes of cuff deflation to allow reperfusion. The cuff inflation periods at the two sites will be staggered, beginning with the upper arm. The first thigh cuff inflation will begin after completion of the first upper-arm cuff inflation, and the alternating sequence will continue until both sites have completed four cycles. The procedure is intended to activate endogenous protective mechanisms and enhance the tolerance of vital organs to subsequent ischemic injury during surgery.

Eligibility criteria

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

Conditions

Aortic Dissection Type A

Locations

  • The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China
  • Fujian Medical University Union Hospital — Fuzhou, Fujian, China
  • The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China
  • Xiamen Cardiovascular Hospital, Xiamen University — Xiamen, Fujian, China
  • The First Affiliated Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China
  • The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjian, China
  • The Fourth Hospital of Harbin Medical University — Harbin, Heilongjian, China
  • Henan Provincial Chest Hospital — Zhengzhou, Henan, China
  • The Second Xiangya Hospital of Central South University — Changsha, Hunan, China
  • The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China
  • Shengjing Hospital of China Medical University — Shenyang, Liaoning, China
  • Qilu Hospital of Shandong University — Jinan, Shandong, China
  • The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China
  • Yan'an Hospital of Kunming City — Kunming, Yunnan, China
  • The Second Affiliated Hospital of AMU — Chongqing, China
  • Renji Hospital — Shanghai, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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