Potassium-competitive Acid Blocker Versus Double Dose Proton Pump Inhibitors in High High-risk Peptic Ulcer Bleeding

ConditionBleeding
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cheng-Kung University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Vonoprazon

    Drug

    After 72 hours continuous intravenous PPI, patients in the intervention group will receive vonoprazon 20mg per day for 28 days.

  • Esomeprazole

    Drug

    After 72 hours continuous intravenous PPI, patients in the intervention group will receive esomeprazole 40mg twice a day for 28 days.

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Standard groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
28 days

Secondary outcomes

1

Requirement for transcatheter arterial embolization or surgical hemostasis because of recurrent bleeding

Requirement for transcatheter arterial embolization or surgical hemostasis because of recurrent bleeding

Time frame
28 days
2

Mortality

All cause mortality within 28 days

Time frame
28 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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