NCT07383909

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,312

participants targeted

Target at P75+ for not_applicable

Timeline
76mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Dec 2032

First Submitted

Initial submission to the registry

December 8, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 29, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

3.8 years

First QC Date

December 8, 2025

Last Update Submit

September 13, 2026

Conditions

Aortic Dissection Type A

Keywords

Remote Ischaemic Conditioningischemia reperfusion injuryemergency surgerymajor adverse outcomes

Outcome Measures

Primary Outcomes (1)

  • 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.

    surgery to discharge or 30 days post-op

Secondary Outcomes (11)

  • Sequential Organ Failure Assessment (SOFA) Score Within the First 3 Postoperative Days

    From postoperative ICU admission through postoperative day 3

  • Operative Time

    During the surgical procedure

  • Duration of Mechanical Ventilation

    From end of surgery until extubation (assessed up to 30 days)

  • ICU Length of Stay

    From ICU admission after surgery until ICU discharge (assessed up to 30 days)

  • Hospital Length of Stay

    From hospital admission for surgery until hospital discharge (assessed up to 30 days)

  • +6 more secondary outcomes

Study Arms (2)

RIPC Intervention Group

EXPERIMENTAL

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)

Control Group

SHAM COMPARATOR

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)

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.

Control GroupRIPC Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years;
  • Acute type A aortic dissection requiring emergency surgery within 14 days of symptom onset;
  • Written informed consent provided by the participant or a legally authorized representative;
  • Willingness to comply with study follow-up.

You may not qualify if:

  • Traumatic or iatrogenic aortic dissection;
  • Previous open cardiac or thoracic aortic surgery;
  • Persistent deep coma (Glasgow Coma Scale score ≤8), abdominal compartment syndrome, preoperative mechanical circulatory support, or norepinephrine-equivalent dose \>0.1 μg/kg/min;
  • Estimated glomerular filtration rate \<30 mL/min/1.73 m², total bilirubin \>342 μmol/L, or international normalized ratio \>2.0;
  • 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;
  • Peripheral arterial disease involving the limbs, Raynaud phenomenon, active phlebitis, or a history of lower-extremity deep vein thrombosis;
  • Current use of sulfonylureas or nicorandil;
  • Expected survival \<1 year;
  • Concurrent participation in another clinical trial that has not yet reached its primary endpoint;
  • Pregnancy or breastfeeding;
  • Immunodeficiency, a known bleeding or coagulation disorder, sickle cell anemia, or active or uncontrolled infection;
  • Any other condition considered unsuitable for enrollment by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

NOT YET RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

NOT YET RECRUITING

Xiamen Cardiovascular Hospital, Xiamen University

Xiamen, Fujian, China

RECRUITING

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

NOT YET RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjian, China

NOT YET RECRUITING

The Fourth Hospital of Harbin Medical University

Harbin, Heilongjian, China

NOT YET RECRUITING

Henan Provincial Chest Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

NOT YET RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

NOT YET RECRUITING

Yan'an Hospital of Kunming City

Kunming, Yunnan, China

NOT YET RECRUITING

The Second Affiliated Hospital of AMU

Chongqing, China

NOT YET RECRUITING

Renji Hospital

Shanghai, China

NOT YET RECRUITING

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Liang-wan Chen, M.D Ph.D

CONTACT

+8613358255333chenliangwan@fjmu.edu.cn

Xin-fan Lin, M.D

CONTACT

+8617850019550lxf1885@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief

Study Record Dates

First Submitted

December 8, 2025

First Posted

February 3, 2026

Study Start

March 29, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2032

Last Updated

September 16, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(16)