Efficacy of Low Dose of Proton Pump Inhibitor in Treatment Bleeding Ulcers

Completed

• Conditions: Gastroduodenal Ulcer; Marginal Ulcer; Peptic Ulcer Hemorrhage
• Interventions: Drug: Omeprazole 40 MG

• Registration Number: NCT03163680
• Lead Sponsor: Damascus Hospital

Brief Summary

Determining the efficacy of low dose of PPI in management acute peptic ulcer bleeding

Detailed Description

Determining the efficacy of low dose meaning 40 mg of omeprazole twice in management acute peptic ulcer bleeding

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-20
• Study First Posted: 2017-05-23
• Primary Completion: 2018-05-01
• Study Completion: 2018-06-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-07
• Last Update Posted: 2018-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 295

Inclusion Criteria

High risk ulcers defined according to the Forrest classification With respect to high-risk stigmata, active bleeding was defined as a continuous blood spurting (Forrest IA) oozing (Forrest IB) from the ulcer base. A non-bleeding visible vessel at endoscopy was defined as a discrete protuberance at the ulcer base(Forrest IIA).

An adherent clot was one that was resistant to forceful irrigation or suction (Forrest IIB).

Exclusion Criteria

ulcer was malignant non ulcerative bleeding such as angiodysplasia , a Mallory-Weiss tear

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low Dose PPI	Omeprazole 40 MG	patients with upper upper gastrointestinal bleeding were treated in low dose of proton Bump inhibitor meaning 40 mg twice daily

Primary Outcome Measures

Name	Time	Method
Morality	within 1 week	Determination of mortality rate from ulcer bleeding

Secondary Outcome Measures

Name	Time	Method
Rebleeding	within 1 week	Determination of the percentage of the return of bleeding represented by recurrent melena (black, tarry stool) or recurrent Hematemesis or coffee-ground emesis or recurrent hematochezia after begin treatment
Length of hospital stay	within 1 month	Determining the length of stay in the hospital
need for surgery	within 1 week	Determine the Surgery rate for treatment Bleeding ulcers within a week
Blood transfusions	within 1 week	number of transfusion blood unites during admission

Trial Locations

Locations (1)

Damascus Hospital; 🇸🇾 Damascus, Syrian Arab Republic