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Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection

Study acronym: STOP
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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
Trial Details
NCT Number NCT07156656
Lead Sponsor Shanghai Zhongshan Hospital
Collaborators: The First Affiliated Hospital of Anhui Medical University, Fujian Provincial Hospital, The University of Hong Kong-Shenzhen Hospital, First Affiliated Hospital Xi'an Jiaotong University, Guangdong Provincial People's Hospital, Changhai Hospital
Conditions
(from sponsor)		 Type A Aortic Dissection, Organ Failure, Multiple
Related terms Multiple Organ Failure
Enrollment 236 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov