Status:
NOT_YET_RECRUITING
Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
The First Affiliated Hospital of Anhui Medical University
Fujian Provincial Hospital
Conditions:
Type A Aortic Dissection
Organ Failure, Multiple
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 dis...
Eligibility Criteria
Inclusion
- Age 18-75 years inclusive.
- Written informed consent obtained before participation.
- Confirmed acute Stanford type A aortic dissection scheduled for surgical repair.
Exclusion
- Life expectancy ≤ 48 hours.
- Pregnant or lactation.
- Severe pre-operative liver dysfunction: Child-Turcotte-Pugh score 10-15.
- Severe pre-operative renal dysfunction: acute or chronic kidney injury meeting criteria for renal-replacement therapy.
- Confirmed COPD or asthma.
- Immunosuppression: long-term or \> 2 weeks continuous systemic corticosteroids.
- Concomitant or anticipated use of immunomodulators (Xue-Bi-Jing injection, thymosin, IVIG).
- Medical or psychological condition that would interfere with study participation, assessment, or outcomes.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT07156656
Start Date
September 1 2025
End Date
September 30 2028
Last Update
September 5 2025
Active Locations (6)
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1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
2
Fujian Provincial Hospital
Fuzhou, Fujian, China
3
Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong Provincial People's Hospital Affiliated to Southern Medical University)
Guangzhou, Guangdong, China
4
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China