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ClinicalTrials.gov ID

NCT07156656

Lead Sponsor

Shanghai Zhongshan HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

236Estimated

Last Update Posted

Sep 5, 2025Actual

Start Date

Sep 1, 2025Estimated

Primary Completion Date

Sep 30, 2028Estimated

Completion Date

Sep 30, 2028Estimated

Official Title

Assessment of the Efficacy of Sivelestat Sodium Treatment in Post-operative Organ Dysfunction in Patients With Acute Type A Aortic Dissection (STOP): a Multicenter, Double-blind RCT

Brief Summary

The goal of this multicenter, double-blind, randomized controlled trial is to learn if sivelestat sodium (Siv) can protect the organ function in patients suffered operation for acute type A aortic dissection. The main questions it aims to answer are:

• Can the 3-day-treatment of Siv enlarge the Day-0-to-Day-5 drop in the organ-health score (SOFA score)?
• Can this treatment significantly shrink the area under the SOFA curve from first dose to Day 5?
• Can this treatment significantly improve the end of patients in 28 days (clinical outcomes)? Researchers will compare drug Siv to a placebo (a look-alike substance that contains no drug) to see if drug Siv works.

Participants will:

• Take drug Siv or the placebo through vein continuously for 72 hours
• Receiving regular intensive care in ICU after the operation

• Type A Aortic Dissection
• Organ Failure, Multiple

• Conventional treatment
• Sivelestat sodium
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Age 18-75 years inclusive.
2. Written informed consent obtained before participation.
3. Confirmed acute Stanford type A aortic dissection scheduled for surgical repair.

Exclusion Criteria:

1. Life expectancy ≤ 48 hours.
2. Pregnant or lactation.
3. Severe pre-operative liver dysfunction: Child-Turcotte-Pugh score 10-15.
4. Severe pre-operative renal dysfunction: acute or chronic kidney injury meeting criteria for renal-replacement therapy.
5. Confirmed COPD or asthma.
6. Immunosuppression: long-term or > 2 weeks continuous systemic corticosteroids.
7. Concomitant or anticipated use of immunomodulators (Xue-Bi-Jing injection, thymosin, IVIG).
8. Medical or psychological condition that would interfere with study participation, assessment, or outcomes.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Shanghai Zhongshan HospitalOTHER

Collaborators

The First Affiliated Hospital of Anhui Medical UniversityOTHER

Fujian Provincial HospitalOTHER

The University of Hong Kong-Shenzhen HospitalOTHER

First Affiliated Hospital Xi'an Jiaotong UniversityOTHER

Guangdong Provincial People's HospitalOTHER

Changhai HospitalOTHER

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