About this trial
This randomized clinical trial will enroll patients at National Cheng Kung University Hospital who have upper gastrointestinal ulcer bleeding, have undergone endoscopic hemostasis, and have a Rockall score of 6 or higher.
A total of 108 patients will be enrolled and randomly assigned to two groups: Standard-treatment group: 54 patients, Experimental group: 54 patients.
Both groups will receive standard endoscopic hemostasis and 72 hours of intravenous PPI therapy. Thereafter, patients in the standard-treatment group will receive double-dose PPI therapy, whereas patients in the experimental group will receive a P-CAB per day. All patients will be followed for 28 days to assess the occurrence of rebleeding.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hospitalized patients > 18 years with upper gastrointestinal ulcer bleeding, a Rockall score of 6 or higher, and treatment with endoscopic hemostasis.
Disqualifiers
history of hypersensitivity to PPIs or P-CABs.
non-ulcer-related bleeding, such as variceal bleeding, angiodysplasia, diverticular bleeding, diffuse mucosal bleeding, or tumor bleeding.
severe hepatic or renal impairment
Trial design
Parallel
Treatments tested in this trial
Vonoprazon
DrugAfter 72 hours continuous intravenous PPI, patients in the intervention group will receive vonoprazon 20mg per day for 28 days.
Esomeprazole
DrugAfter 72 hours continuous intravenous PPI, patients in the intervention group will receive esomeprazole 40mg twice a day for 28 days.
Treatment groups
Trial outcomes
Primary outcomes
Recurrent bleeding
If melena or hematochezia occurs during follow-up, endoscopy will be performed to determine whether recurrent bleeding originates from the original bleeding lesion.
Secondary outcomes
Requirement for transcatheter arterial embolization or surgical hemostasis because of recurrent bleeding
Requirement for transcatheter arterial embolization or surgical hemostasis because of recurrent bleeding
Mortality
All cause mortality within 28 days
Locations
Sponsors and contacts
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