NCT07156656

Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Type A Aortic Dissection
• Organ Failure, Multiple

Interventions

Type	Name	Description
PROCEDURE	Conventional treatment	Beside the using of Sivelestat Sodium or placebo, all postoperative care will adhere to each center's standard protocols for type A aortic dissection.
DRUG	Sivelestat sodium	The daily dose (4.8 mg/kg) is diluted in 48 mL of 0.9 % saline and administered as a continuous intravenous infusion over 24 hours at 2 mL/h (equivalent to 0.2 mg/kg/h) for 72 consecutive hours.
DRUG	Placebo	An equal volume of placebo-containing only the excipients of sivelestat sodium and diluted to 48 mL with 0.9 % saline-will be infused at 2 mL/h for 72 consecutive hours.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-09-30
• Completion: 2028-09-30
• First posted: 2025-09-05
• Last updated: 2025-09-05

Locations

6 sites across 1 country: China