Peptic ulcer bleeding
Conditions
Interventions
Test Group 1:Intravenous administration of fumaric acid volnorex injection for the trial (initial dosage concentration: 20mg/100mL)
Test Group 2:Intravenous administration of fumaric acid volnorex injection for the trial (initial dosage concentration: 40mg/100mL)
Control group:The initial administration involves the injection of esomeprazole sodium dissolved in saline (80mg:100mL), completed within 30+/-3 minutes. Subsequently, a prepared injection of esomepra
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate and sign the informed consent form; 2. 18 years old<= age<= 75 years old, gender is not limited; 3. Other clinical manifestations of upper gastrointestinal bleeding such as hematemesis, melena or positive fecal occult blood within 48 hours before screening; 4. Patients with upper gastrointestinal bleeding caused by gastric and/or duodenal ulcer confirmed by endoscopy within 24 hours before randomization, with a maximum diameter range of 3-20mm; 5. Peptic ulcer Forrest classification is I.a, I.b, II.a, II.b, multiple ulcers are judged according to the Forrest grade, and those who are confirmed to have successful hemostasis after endoscopic treatment, the requirements for endoscopic treatment are as follows: (1) Forrest Ia, Ib, II.a: Thermocoagulation hemostasis or mechanical hemostasis is used as the main means, and local epinephrine drug injection is also allowed on the basis of the above main means; (2) Forrest IIb: In order to confirm the specific grade, it is necessary to try endoscopic irrigation to remove the attached blood clot first, if the blood clot is removed, the Forrest grade will be evaluated again, and if it is Forrest Ia, Ib, II.a, endoscopic hemostatic therapy will be carried out according to the above requirements; Direct enrollment is allowed if the clot is not cleared, i.e., it is finally confirmed as Forrest IIb.
Exclusion criteria
Exclusion criteria: 1. Individuals with a clinically significant history of drug allergies or known allergies to the components and excipients of the study drug; 2. Subjects with other severe central nervous system, cardiovascular, respiratory, liver, kidney, gastrointestinal, urinary, endocrine, or hematological diseases, where the investigator believes it may confound the study results or affect the safety of the subjects; 3. Coagulation dysfunction: (1) Platelets =1.5×ULN; (2) Total bilirubin >1.5×ULN; (3) Serum creatinine (Cr) > ULN; (any one of these criteria disqualifies the patient from enrollment) 5. A history of drug abuse within the last 5 years; 6. Receipt of live vaccines or attenuated live vaccines within 30 days prior to the first administration, or plans to receive vaccinations during the study period; 7. Hemorrhagic shock (occurrence of systolic blood pressure 120 beats/min during the screening period, accompanied by symptoms such as pallor, cold extremities, restlessness, or altered mental status) or failure of endoscopic treatment requiring arterial catheter embolization or surgical intervention; 8. Concurrent upper gastrointestinal bleeding from other causes or suspected gastric malignancy during endoscopy; 9. There is a clear history of surgery to reduce gastric acid or a history of gastric surgery (including but not limited to partial gastrectomy, gastric reconstruction, vagotomy, excluding simple perforation suturing); 10. Individuals with a history of malignant tumors within the last 5 years prior to screening (if the subject has been cured of basal cell carcinoma of the skin or cervical carcinoma in situ, he/she may participate in this study); 11. Individuals who have used proton pump inhibitors (PPIs) or H2 receptor antagonists or P-CAB agents exceeding the standard single dose within 24 hours prior to screening, or who have completed endoscopic treatment/intervention before signing the informed consent form, and have used PPIs, P-CAB agents, H2 receptor antagonists, somatostatin, or hemostatic agents after endoscopic treatment/intervention until entering this study; 12. Patients currently using drugs with a clear risk of interaction with the investigational drug, such as azanavir sulfate, nelfinavir, saquinavir, or lopinavir, at the time of screening; 13. Use of hemostatic powder Endoclot AHP® or other local hemostatic agents during endoscopy that the investigator deems may affect the efficacy of the investigational drug during the screening period; 14. Pregnant or breastfeeding women, as well as those planning to become pregnant or donate sperm or eggs within 3 months after the end of the study, who are unwilling to use a medically recognized contraceptive method (such as an intrauterine device or condom) during the study period; 15. Individuals who participated in other drug/device clinical studies and used investigational drugs/devices within 3 months prior to randomization; 16. Other subjects deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rebleeding rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Transfusion rate and average transfusion volume;The proportion of subjects requiring re-endoscopic hemostatic treatment.;The proportion of subjects requiring surgical treatment.;Mortality rate of subjects; | — |
Countries
China
Contacts
Public ContactAiming Yang
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed