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

• ClinicalTrials.gov Identifier: NCT00164866
• Recruitment Status: Completed
• First Posted: September 14, 2005
• Last Update Posted: June 6, 2007
• Sponsor: Chinese University of Hong Kong
• Information provided by: Chinese University of Hong Kong

Tracking Information

• First Submitted Date: September 12, 2005
• First Posted Date: September 14, 2005
• Last Update Posted Date: June 6, 2007
• Study Start Date: February 2004
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: June 5, 2007): 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.
• Original Primary Outcome Measures (submitted: September 12, 2005): 30-days survival

Current Secondary Outcome Measures (submitted: June 5, 2007)

• 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
• Hospital stay
• Transfusion requirement

Original Secondary Outcome Measures (submitted: September 12, 2005)

• • Control of bleeding (absence of active bleeding) at the time of endoscopic procedure
• • The prevalence of stigmata of bleeding at endoscopic examination
• • The need for endoscopic treatment (urgent intervention before scheduled endoscopy) and at scheduled endoscopy
• • Hospital stay
• • Transfusion requirement

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Administration of High-Dose Intravenous Proton Pump Inhibitor for Upper Gastrointestinal Bleeding Prior to Endoscopy
• Official Title: Administration of Intravenous Proton Pump Inhibitor Prior to Endoscopy [APPE] in Patients With Upper Gastrointestinal Bleeding; a Double-Blind Placebo-Controlled Randomised Study.

Brief Summary

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.

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
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Peptic Ulcer
• Intervention: Drug: Omeprazole
• Study Arms: Not Provided

Publications *

• Tsoi KK, Lau JY, Sung JJ. Cost-effectiveness analysis of high-dose omeprazole infusion before endoscopy for patients with upper-GI bleeding. Gastrointest Endosc. 2008 Jun;67(7):1056-63. doi: 10.1016/j.gie.2007.11.056. Epub 2008 Apr 14.
• Lau JY, Leung WK, Wu JC, Chan FK, Wong VW, Chiu PW, Lee VW, Lee KK, Cheung FK, Siu P, Ng EK, Sung JJ. Omeprazole before endoscopy in patients with gastrointestinal bleeding. N Engl J Med. 2007 Apr 19;356(16):1631-40.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 12, 2005): 638
• Original Enrollment: Same as current
• Study Completion Date: September 2005
• Primary Completion Date: Not Provided

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT00164866
• Other Study ID Numbers: APPE
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Chinese University of Hong Kong
• Collaborators: Not Provided

Investigators

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

• PRS Account: Chinese University of Hong Kong
• Verification Date: June 2007