Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT07156656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOP
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
* 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: