Different Dose of Intravenous Omeprazole to Treat Bleeding Ulcer With Adherent Clot
Condition: Peptic Ulcer; Hemorrhage
MeSH terms: Peptic Ulcer; Ulcer; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators will include those patients with adherent clot on gastric or duodenal
      ulcers after endoscopic confirmation After receiving well explanation and giving written
      consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first
      group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second
      group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients
      in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd
      for further treatment of peptic ulcer.

      The investigators define rebleeding during admission and within 30 days as primary end points
      and define surgical intervention for ulcer bleeding, transfusion amount and hospitalization
      days after allocation as secondary end points.
    

Detailed description: 
      The investigators will include those patients with adherent clot on gastric or duodenal
      ulcers after endoscopic confirmation and exclusion of other possible bleeder. Adherent clot
      is defined that still stays on the ulcer after 200 ml normal saline irrigation (4 times of
      irrigation with 50 ml syringe). After receiving well explanation and giving written consent,
      they are enrolled and will be allocated to 2 groups randomly. Those in the first group will
      receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second group will
      receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients in both
      groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd for
      further treatment of peptic ulcer. The investigators will record the basic data of these
      patients including age, sex, use of NSAID or anit-coagulant, concomitant major diseases;
      clinical data including Hb, Plt, PT, the lowest systolic pressure before allocation and heart
      rate at the same time, shock status, transfusion amount before allocation; endoscopic
      findings including the location & size of ulcer, size of clot, existence of fresh blood in
      stomach or duodenum. The investigators will monitor the events of rebleeding during admission
      and within 30 days, surgery for ulcer bleeding and mortality within 30 days and record the
      amount of transfusion and hospitalization days after allocation. When rebleeding is suspected
      , those patient will receive endoscopic examination and appropriate therapy. Further
      treatment with surgical or angiographic intervention is decided by the attending
      physicians.These patients will be monitored during admission (2 weeks in average)and then
      followed up in GI outpatient clinics.

      The investigators define rebleeding during admission and within 30 days as primary end
      points. Rebleeding is defined as the one of the clinical manifestations occurring 6 hours
      after allocation: 1.hematemesis or bloody stool 2. tarry stool and hemodynamic change
      (systolic pressure less than 90 mmHg, or heart more than 110 beats per minute ) 3. decrease
      of Hb more than 2g/dl within 24 hours after elevation of Hb to 10 g/dl with transfusion. The
      investigators define surgical intervention for ulcer bleeding, transfusion amount and
      hospitalization days after allocation as secondary end points.
    

Intervention name(s): omeprazole; omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days; receive intravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days
Other intervention name(s): Losec, iv, high dose; Losec, iv, usual dose
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peptic ulcer bleeding; blood clot; dose