An interventional study of Remote ischemic preconditioning (RIPC) in Aortic Dissection Type A, sponsored by Fujian Medical University. Recruiting at 16 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Fujian Medical University · Not applicable, Interventional, and Treatment
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.
Study Design and Rationale
This study is a multicenter, prospective, double-blind, randomized, sham-controlled clinical trial designed to evaluate the organ-protective efficacy and safety of remote ischemic preconditioning (RIPC) in patients undergoing emergency surgery for acute type A aortic dissection (ATAAD).
Primary Objective
The primary objective of this study is to determine whether RIPC reduces the incidence of the primary composite endpoint of major adverse outcomes occurring from the time of surgery until hospital discharge (or up to 30 days postoperatively if hospitalization exceeds 30 days). This composite endpoint includes perioperative all-cause mortality and severe complications requiring invasive intervention or resulting in organ failure.
Key Interventions and Methodology Intervention Group
After induction of general anesthesia, patients in the intervention group will undergo RIPC. RIPC will be performed alternately on one upper arm and one thigh for a total of four cycles, beginning with cuff inflation on the upper arm.
Each cycle consists of 5 minutes of cuff inflation (baseline pressure of 200 mm Hg; or at least 15 mm Hg above systolic pressure if systolic pressure exceeds 185 mm Hg), followed by 5 minutes of cuff deflation to allow reperfusion. The first cycle of the thigh cuff is initiated after completion of the first inflation cycle of the upper arm cuff.
Control Group
Patients in the control group undergo a sham procedure identical in timing and application sites to the RIPC intervention. However, the cuff is inflated to a low, non-ischemic pressure of 20 mm Hg for 5 minutes, followed by 5 minutes of deflation in each cycle.
Blinding
This study employs a double-blind design. Study participants, surgical teams, postoperative care providers, outcome assessors, and data analysts/statisticians are all blinded to treatment allocation. Only an independent researcher, who does not participate in subsequent patient assessment or data collection, is unblinded in order to perform the assigned intervention.
Standardization
All surgical procedures and perioperative care are conducted in accordance with standardized protocols at each participating center.
Study Endpoints Primary Endpoint
The incidence of the primary composite endpoint of major adverse outcomes from surgery until hospital discharge (or up to 30 days postoperatively).
Secondary Endpoints
Secondary endpoints include the incidence of each individual component of the primary composite endpoint at 30 days, 3 months, and 12 months after surgery; Sequential Organ Failure Assessment (SOFA) scores recorded during the first 3 postoperative days; the incidence of postoperative delirium; durations of surgery, cardiopulmonary bypass, and mechanical ventilation; lengths of intensive care unit (ICU) and hospital stay; cardiac troponin and serum creatinine levels within the first 3 postoperative days; 12-month survival; and the incidence of unplanned rehospitalization within 12 months.
Quality Assurance and Data Management Site Selection and Training
Participating centers are required to have substantial experience in emergency ATAAD surgery. All investigators undergo centralized training on the study protocol and Standard Operating Procedures (SOPs), with a focus on the standardized RIPC procedure and data collection.
Clinical Monitoring
Clinical Research Associates (CRAs) conduct periodic on-site monitoring visits to ensure adherence to the study protocol and to verify consistency between data entered in the electronic Case Report Forms (eCRFs) and source documents.
Statistical Analysis
The primary analysis will be conducted in the intention-to-treat (ITT) population. Continuous variables will be compared using appropriate parametric or non-parametric tests, and categorical variables will be compared using the chi-square test or Fisher's exact test, as appropriate.
Sample Size Justification
Based on previously reported literature indicating an incidence of major adverse outcomes of approximately 25.8% after ATAAD surgery, and assuming an anticipated relative risk reduction of 26.5% with RIPC, sample size calculations using a two-sided alpha level of 0.05 and 80% statistical power determined that 589 evaluable patients are required per group. Allowing for an estimated dropout rate of 10%, the final target enrollment for this study is 1,312 patients.
Interim Analysis and Data Safety Monitoring
An independent Data and Safety Monitoring Board (DSMB) will oversee participant safety throughout the study and periodically review aggregated safety data.
A pre-specified blinded sample size re-estimation will be performed when approximately 600 participants have completed assessment of the primary endpoint. This analysis will be based on the pooled event rate and observed dropout rate only, without unblinding treatment allocation or conducting between-group efficacy comparisons. Therefore, the interim analysis will not affect the overall type I error rate.
260 studies on the registry are indexed under Reperfusion Injury; 43 are open to participants now.
This study's planned enrollment of 1,312 is above the median of 60 across 212 interventional studies indexed under Reperfusion Injury.
Browse Reperfusion Injury studies →Fujian Medical University is the lead sponsor of 148 studies on the registry; 52 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this group will receive remote ischemic preconditioning (RIPC) after induction of general anesthesia. RIPC will be performed on the upper arm and thigh, with four ischemia-reperfusion cycles at each site. Each cycle consists of 5 minutes of cuff inflation at 200 mmHg (or 15 mmHg above systolic blood pressure if systolic blood pressure exceeds 185 mmHg), followed by 5 minutes of deflation. Cuff inflation will alternate between the upper arm and thigh, beginning with the upper arm, until four cycles have been completed at each site.
Procedure: Remote ischemic preconditioning (RIPC)
Participants randomized to this group will receive a sham RIPC procedure. The same cuff placement and timing as the experimental group are used, but the cuff is inflated to only 20 mmHg for 5 minutes followed by 5 minutes of deflation, simulating the RIPC procedure without inducing ischemia.
Procedure: 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.
In-hospital major adverse outcomes
A composite of major adverse outcomes (binary). Includes: Perioperative all-cause death; Severe post-op complications (Grade III/IV per IAASSG consensus), involving neurological, cardiovascular, respiratory, urinary, gastrointestinal, and other systems.
Time frame: surgery to discharge or 30 days post-op
Sequential Organ Failure Assessment (SOFA) Score Within the First 3 Postoperative Days
The Sequential Organ Failure Assessment (SOFA) score evaluates dysfunction across six organ systems: brain, respiratory, cardiovascular, liver, kidney, and hemostasis. Each organ system is scored from 0 to 4, yielding a total score ranging from 0 to 24. Higher scores indicate more severe organ dysfunction and a worse outcome. SOFA scores will be recorded within the first 3 postoperative days.
Time frame: From postoperative ICU admission through postoperative day 3
Operative Time
Operative and cardiopulmonary bypass-related time parameters, including total operative duration, cardiopulmonary bypass duration, aortic cross-clamp duration, and circulatory arrest duration. All durations will be measured in minutes.
Time frame: During the surgical procedure
Duration of Mechanical Ventilation
Total time from the end of surgery until successful extubation, measured in hours. Re-intubation times are included if applicable
Time frame: From end of surgery until extubation (assessed up to 30 days)
ICU Length of Stay
Total duration of stay in the Intensive Care Unit after surgery, measured in hours
Time frame: From ICU admission after surgery until ICU discharge (assessed up to 30 days)
Hospital Length of Stay
Total duration of hospitalization after surgery, measured in days
Time frame: From hospital admission for surgery until hospital discharge (assessed up to 30 days)
All-cause mortality
All-cause mortality
Time frame: 30 days, 90 days, 12 months, and every 12 months thereafter, up to 60 months
Postoperative delirium
Incidence of postoperative delirium
Time frame: From the end of surgery until hospital discharge, assessed up to 30 days postoperatively
Unplanned readmission
The proportion of patients readmitted to the hospital within the follow-up period due to causes related to the original acute type A aortic dissection or its surgical treatment, excluding planned readmissions
Time frame: 30 days, 90 days, 12 months, and every 12 months thereafter, up to 60 months
Incidence of any individual component of the primary composite endpoint at 30 days, 90 days, and 12 months postoperatively
Incidence of each individual adverse event (including death, stroke, renal failure, reoperation, etc.) that constitutes the primary composite endpoint of Major Adverse Outcomes (MAO) at 30 days, 90 days, and 12 months after surgery.
Time frame: 30 days, 90 days, and 12 months postoperatively
Postoperative Serum Cardiac Troponin Concentration
Serum cardiac troponin concentration will be measured during the first 3 postoperative days. Cardiac troponin I or cardiac troponin T will be measured according to the routine assay used at each participating center.
Time frame: Postoperative days 1-3
Postoperative Serum Creatinine Concentration
Serum creatinine concentration will be measured during the first 3 postoperative days and reported in μmol/L.
Time frame: Postoperative days 1-3
Plan to share: No
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