Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection (STOP)

Fudan University

Status and phase: Not yet enrolling; Phase 4

Conditions: Organ Failure, Multiple; Type A Aortic Dissection

Treatments: Drug: Sivelestat sodium; Drug: Placebo; Procedure: Conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07156656

B2025-349R

Details and patient eligibility

About

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

Enrollment: 236 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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236 participants in 2 patient groups, including a placebo group

Sivelestat group

Experimental group

Description:

Drug: Sivelestat Sodium. Procedure: Conventional Treatment

Treatment:

Procedure: Conventional treatment

Drug: Sivelestat sodium

Control group

Placebo Comparator group

Description:

Drug: Placebo. Procedure: Conventional Treatment

Treatment:

Drug: Placebo

Procedure: Conventional treatment