Actively Recruiting
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
Led by Fujian Medical University · Updated on 2026-02-03
1296
Participants Needed
3
Research Sites
204 weeks
Total Duration
On this page
Sponsors
F
Fujian Medical University
Lead Sponsor
T
The First Affiliated Hospital of Dalian Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether a procedure called remote ischemic preconditioning (RIPC) can help protect organs during emergency surgery for acute type A aortic dissection (ATAAD). The trial aims to find out if RIPC can reduce major complications like heart, brain, or kidney problems after surgery, and whether it is safe to use. This multicenter, randomized, double-blind trial compares patients receiving RIPC to those undergoing a sham procedure during their surgery. Patients in the RIPC group receive four cycles of cuff inflation and deflation on the upper arm and thigh to induce brief periods of ischemia and reperfusion after anesthesia starts. The control group gets a similar procedure with low-pressure cuff inflation that does not cause ischemia. Both procedures alternate between the arm and thigh. Surgical and perioperative care follow standardized protocols across centers. Participants are randomly assigned to either group without knowing which one they receive. Participants are monitored for major adverse outcomes until hospital discharge or up to 30 days after surgery. Follow-up visits occur at 3 months, 1 year, and then annually for up to 5 years to assess recovery. Researchers collect data on complications, organ function scores, ventilation duration, length of ICU and hospital stay, mortality, and rehospitalization rates. Safety is overseen by an independent board, and data quality is ensured through monitoring and training. The total study duration per participant extends up to 5 years post-surgery.
CONDITIONS
Brief Title
Remote Ischemic Preconditioning for Aute Type A Aortic Dissection Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any sex
- Diagnosed with acute Type A aortic dissection requiring emergency surgery with symptom onset less than 14 days
- Ability to understand the study and provide written informed consent or have a legally authorized representative do so
- Willingness to comply with follow-up visits
You will not qualify if you...
- Traumatic or iatrogenic aortic dissection
- Previous open cardiac or thoracic aortic surgery
- Severe preoperative organ dysfunction such as persistent coma, abdominal compartment syndrome, or circulatory failure
- Severe comorbidities including recent myocardial infarction (within 7 days), recent stroke (within 2 months), end-stage kidney or liver disease
- Ischemia or severe deformity at limb planned for intervention
- Peripheral arterial disease, Raynaud phenomenon, active phlebitis, or history of deep vein thrombosis in the lower limbs
- Current use of sulfonylurea oral hypoglycemic agents or nicorandil
- Life expectancy under 1 year due to conditions like advanced cancer
- Participation in another clinical trial without completion of its primary endpoint
- Pregnancy or lactation; immunodeficiency; bleeding disorders; active or uncontrolled infection
- Other severe physical or psychiatric disorders or lab abnormalities increasing risk or interfering with study outcomes
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants undergo emergency surgery for acute type A aortic dissection. After induction of general anesthesia, participants receive either remote ischemic preconditioning (RIPC) involving four alternating cycles of cuff inflation and deflation on the upper arm and thigh, or a sham procedure. The treatment is administered during the surgery period.
1 surgical procedure visit (in-person)
Duration - Up to 30 days
Participants are monitored for major adverse outcomes and recovery after surgery until hospital discharge or up to 30 days postoperatively. This includes assessments of organ function, mechanical ventilation duration, ICU and hospital length of stay, and postoperative complications.
Daily in-hospital assessments and follow-up visits until discharge
Duration - Up to 60 months
Participants undergo assessments for survival, adverse outcomes, and unplanned readmissions at 30 days, 90 days, 12 months, and annually up to 60 months after surgery to evaluate long-term safety and efficacy.
Scheduled follow-up visits at 30 days, 90 days, 12 months, and annually thereafter
Trial Site Locations
Total: 3 locations
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
2
Xiamen Cardiovascular Hospital, Xiamen University
Xiamen, Fujian, China
Not Yet Recruiting
3
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Not Yet Recruiting
Research Team
L
Liang-wan Chen, M.D Ph.D
X
Xin-fan Lin, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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