Peptic Ulcer With Haemorrhage
Conditions
Brief summary
Upper gastrointestinal hemorrhage (UGIH) is common urgency condition.The estimate mortality rate about 7 percent from peptic ulcers disease(PUD). A proton pump inhibitors (PPIs) intravenous infusion are standard treatment for high risk ulcer bleeding. Vonoprazan,subclass of potassium-competitive acid blockers (P-CABs), have beneficial effects including rapid, long-lasting and strong acid suppression.The investigators design a randomized-controlled trial comparison between 72 hours of intravenous PPIs infusion and oral vonoprazan in high risk ulcer UGIH after achieve endoscopic hemostasis. Outcome measurement are re-bleeding rate in 30 days as primary and re-bleeding rate in 3 days, 30 days mortality, rate of angioembolisation, unit of blood transfusion, hospital cost and length of stay as secondary outcome.
Interventions
DRUGVonoprazan
Vonoprazan 20 mg oral every 12 hours (total 72 hours)
DRUGPPIs IV infusion
Pantoprazole 80 mg IV loading then 8 mg/hr
Sponsors
Uayporn Kaosombatwattana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* High risk peptic ulcers bleeding (Forrest class Ia,Ib,IIa,IIb)
Exclusion criteria
* Patients were not achieve endoscopic hemostasis * End stage cancer disease * Severe critical illness and ICU setting * Uncorrectable coagulopathy * Pregnancy or breast feeding * Allergy to PPIs or Vonoprazan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rebleeding rate | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Length of stay | Until discharge, assessed up to 30 days |
| Rebleeding rate | 3 days |
| Mortality rate | 30 days |
| Number of blood transfusion unit | 30 days |
| Rate of immobilisation or surgery | 30 days |
Countries
Thailand
Outcome results
None listed