Administration of High-Dose Intravenous Proton Pump Inhibitor for Upper Gastrointestinal Bleeding Prior to Endoscopy

June 5, 2007 updated by: Chinese University of Hong Kong

Administration of Intravenous Proton Pump Inhibitor Prior to Endoscopy [APPE] in Patients With Upper Gastrointestinal Bleeding; a Double-Blind Placebo-Controlled Randomised Study.

To evaluate if intravenous PPI infusion, when administered prior to endoscopy, hastens resolution of bleeding stigmata and thereby facilitates endoscopic examinations and reduces the need for endoscopic treatment. Clot stabilization may itself sustain control of bleeding before endoscopy. These may translate into improved patients'outcome and survival.

To determine the therapeutic effect of high-dose PPI infusion in upper gastrointestinal bleeding from causes other than peptic ulcers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A placebo-controlled randomised study is being proposed. We hypothesize that early administration of intravenous omeprazole infusion stabilizes clots overlying arteries and hastens resolution of bleeding stigmata in peptic ulcer, and facilitates subsequent endoscopic examinations and reduces the need for endoscopic treatment. This may translates into clinical benefits in those who receive early intravenous omeprazole.

Consecutive patients with overt signs of upper gastrointestinal bleeding will be randomised to receive omeprazole or its equivalent placebo (80mg i.v. bolus followed by 8mg/hr) until next scheduled endoscopy. Patients with circulatory instability or fresh hematemesis will undergo endoscopic examinations urgently after initial stabilisation. The infusion will continue until endoscopic examination with or without therapy. Next scheduled endoscopy is performed within 24 hours from admission by experienced endoscopists with expertise in therapeutic endoscopy. At endoscopy, actively bleeding ulcers or ulcers with non-bleeding visible vessels are to be treated by endoscopic therapy. Omeprazole infusion 8mg/hr is to be continued for 72 hours after endoscopic hemostasis.

Patients will be followed-up for 30 days from the time of admission or if patients stay longer than 30 days, the time to hospital discharge or death.

Study Type

Interventional

Enrollment

638

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong SAR, China
        • Endoscopy Center, Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with overt signs of upper GIB; fresh hematemesis and/or melena with or with circulatory compromise

Exclusion Criteria:

  • Chronic aspirin user,
  • Pregnancy,
  • Age<16,
  • Allergy to PPI,
  • No consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
early intranvenous infusion of a high-dose poton-pump inhibitor before endoscopy would have a therapeutic effect on bleeding ulcers, reduce the need for endoscopic therapy, and result in improved clinical outcomes.

Secondary Outcome Measures

Outcome Measure
Hospital stay
Control of bleeding (absence of active bleeding) at the time of endoscopic procedure
The prevalence of stigmata of bleeding at endoscopic examination
30-day survival
Transfusion requirement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: James Y Lau, MD, Endoscopy Center, Prince of Wales Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 14, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 6, 2007

Last Update Submitted That Met QC Criteria

June 5, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APPE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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