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Remote Ischemic Preconditioning for Aute Type A Aortic Dissection Surgery
Sponsor: Fujian Medical University
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1312
Start Date
2026-03-29
Completion Date
2032-12-31
Last Updated
2026-09-16
Healthy Volunteers
No
Conditions
Interventions
Remote ischemic preconditioning (RIPC)
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.
Locations (16)
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