Actively Recruiting
Timing of Endoscopic Intervention for Acute Variceal Hemorrhage: an RCT
Led by Jinling Hospital, China · Updated on 2025-11-24
400
Participants Needed
4
Research Sites
253 weeks
Total Duration
On this page
Sponsors
J
Jinling Hospital, China
Lead Sponsor
T
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborating Sponsor
AI-Summary
What this Trial Is About
Acute variceal upper gastrointestinal hemorrhage remains a hot potato in cirrhotic patients. The purpose of this study is to figure out whether urgent endoscopy (within 6h after gastroenterological consultation) is superior to non-urgent endoscopy (between 6h and 24h after gastroenterological consultation) in reducing rebleeding for these patients. This is a multi-centered, prospective, randomized, and controlled trial. 400 patients with suspected variceal bleeding will be randomized in a 1:1 ratio to receive endoscopic intervention either within 6h or 6-24h. Randomization is conducted by permuted block randomization stratified by age, systolic blood pressure (SBP), and pulse rate. The primary efficacy endpoint is rebleeding within 42 days after control of acute variceal hemorrhage. This trial will provide valuable insights into the efficacy between the urgent endoscopy group and the non-urgent endoscopy group.
CONDITIONS
Official Title
Timing of Endoscopic Intervention for Acute Variceal Hemorrhage: an RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with pathological or clinical and imaging evidence of cirrhosis
- Patients with clinical symptoms of acute variceal hemorrhage such as hematemesis, melena, or hematochezia before admission or during hospitalization
- Patients who are hemodynamically stable before or after initial fluid resuscitation
You will not qualify if you...
- Pregnancy
- Lactation
- Under 18 years of age
- History of taking anticoagulant or antiplatelet drugs within 2 weeks prior to admission
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Affiliated Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China, 210002
Actively Recruiting
2
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
3
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
4
The Affiliated Wuxi People's Hospital of Nanjing Medical University
Wuxi, Jiangsu, China, 214043
Actively Recruiting
Research Team
Z
Zhuoxin Yang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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