Upper gastrointestinal bleeding
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Sign the written informed consent before joining the group. 2) Aged 18-70 years. 3) Acute upper gastrointestinal bleeding was clinically diagnosed within 24 hours before enrollment. 4) Gastroscopy within 24 hours after admission confirmed the presence of gastric or duodenal ulcer bleeding. The maximum diameter of the ulcer ranges from 3 to 15 mm, and the Forrest classification is Ia, Ib, IIa or IIb. 5) Endoscopic hemostasis has been successfully completed (it is clear that the bleeding has stopped, and the previous bleeding vessels are flat or forming a vascular cavity when possible, it is considered that the bleeding has been successfully stopped): treatment methods include but not limited to injection/spray therapy (epinephrine) , Diluted according to the ratio of 1:10000), thermal probe coagulation, electrocautery, hemostatic clip, etc.
Exclusion criteria
Exclusion criteria: 1) According to the judgment of the investigator, patients with malignant tumors or other progressive diseases whose life expectancy is less than 6 months. 2) The investigator judges that gastric malignancy or parapyloric stenosis is suspected under endoscopy. 3) Patients with multiple peptic ulcer bleeding, or gastrointestinal bleeding caused by the following reasons: esophageal varices, reflux esophagitis, gastritis, Mallory-Weiss syndrome, simple ulcer, Dieulafoy disease, colon, small intestine Or patients with distal gastric ulcers after gastric resection. 4) Patients with severe liver disease are defined as Child-Pugh B or C grade. 5) Patients with severe renal disease, defined as patients with creatinine clearance less than 60 mL/min (using Cockcroft-Gault method). 6) According to the judgment of the investigator, major cardiovascular events such as stroke, myocardial infarction or hospitalization due to unstable angina occurred at the time of enrollment or within 3 months before enrollment. 7) Patients with coagulation dysfunction, platelets 1.5, APTT > 1.5 times the upper limit of normal (ULN), or patients receiving low molecular weight heparin therapy. 8) It is necessary to continue treatment with non-steroidal anti-inflammatory drugs, cyclooxygenase-2 (COX-2) inhibitors, acetylsalicylic acid (ASA) (including small doses) or clopidogrel. 9) Subjects who are using or need to continue to use drugs that may interact with ilaprazole or esomeprazole: warfarin (including other vitamin K antagonists), cisapride, phenytoin, Atazanavir, Nefinavir, Ritonavir, Saquinavir, Digoxin, Tacrolimus, Methotrexate. 10) Known pregnancy or a positive pregnancy test. 11) Known or suspected effects on any PPI (ilaprazole, esomeprazole, omeprazole, lansoprazole, dexlansoprazole, rabeprazole or pantoprazole) and Allergy to excipients. 12) Participated in other clinical studies within 30 days before screening. 13) Patients with known or suspected alcoholism, drug abuse, or drug abuse. 14) Any PPI or H2RA therapy was used in the 12 hours before random assignment. The researcher believes that the subject has other conditions that are not suitable for participating in clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rebleeding rate within 72 hours (including 72 hours) after effective endoscope hemostasis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who received endoscopic retreatment or surgery due to gastrointestinal bleeding within 72 hours (including 72 hours) after effective hemostasis by endoscopy;The gastrointestinal rebleeding rate within 7 days (including 7 days) after effective endoscope hemostasis;The incidence of adverse reactions in each group; | — |
Countries
China
Contacts
Public ContactFeng Ji, Jianzhong Shentu
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed