China Survey of Peptic Ulcer Bleeding

Completed

• Conditions: Peptic Ulcer Hemorrhage

• Registration Number: NCT01241266
• Lead Sponsor: AstraZeneca

Brief Summary

This will be a multicenter prospective observational study carried out in China. The investigators will collect data in a pre-specified Case Report Form. Main data from each patient will include demographics, endoscopy classification, and both endoscopy and pharmacological treatments received by patients. Data from each patient will be prospectively collected from the day the patient is diagnosed as peptic ulcer bleeding by endoscopy and receives endoscopy treatment if the investigator thinks it is needed and up to 30 days afterwards. The proportion of peptic ulcer bleeding patients who are at high risk is the primary outcome variable. High risk is defined as the patients with endoscopy Forrest classification Ia to IIb. The rate and type of endoscopic treatment, the rate of successful endoscopy treatment, the re-bleeding rate and the endoscopic re-treatment rate in high risk peptic ulcer bleeding patients will be collected. The surgery rate and mortality rate in high risk and overall patient population will be calculated.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-16
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-29
• Last Update Posted: 2011-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1044

Inclusion Criteria

• Female and/or male aged 18 years and above
• Admitted to the hospital with an overt upper GI bleeding (hematemesis/coffee ground vomiting, melena, hematochezia and other clinical or laboratory evidence of acute blood loss from the upper GI tract)
• Endoscopy demonstrated peptic ulcer bleeding (Forrest I-III)

Exclusion Criteria

• If participating in any clinical trial, the subject cannot take part in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb).	1 day

Secondary Outcome Measures

Name	Time	Method
The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb) and receiving endoscopic treatment	1 day
The proportion of patients receiving endoscopic treatments by type of endoscopic treatmentendoscopic treatment	5 day
The clinically significant re-bleeding rate of high risk (Forrest Ia-IIb) peptic ulcer bleeding patients treated with or without PPI or H2RA, at 3, 5 and 30 days after successful endoscopy treatment.	30 days

Trial Locations

Locations (1)

Research Site; 🇨🇳 Wenzhou, Zhejiang, China