China Survey of Peptic Ulcer Bleeding (PUB)

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.

Study Overview

• Status: Completed
• Conditions: Peptic Ulcer Hemorrhage

• Study Type: Observational
• Enrollment (Actual): 1044

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Research Site
  • Beijing
    • Beijing, Beijing, China
      • Research Site
  • Chongqing
    • Chongqing, Chongqing, China
      • Research Site
  • Fujian
    • Fuzhou, Fujian, China
      • Research Site
    • Xiamen, Fujian, China
      • Research Site
  • Gansu
    • Lanzhou, Gansu, China
      • Research Site
  • Guangdong
    • Guangzhou, Guangdong, China
      • Research Site
    • Shenzhen, Guangdong, China
      • Research Site
  • Heilongjiang
    • Haerbin, Heilongjiang, China
      • Research Site
  • Hubei
    • Wuhan, Hubei, China
      • Research Site
  • Hunan
    • Changsha, Hunan, China
      • Research Site
  • Jiangsu
    • Jiangyin, Jiangsu, China
      • Research Site
    • Nanjing, Jiangsu, China
      • Research Site
    • Nantong, Jiangsu, China
      • Research Site
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Research Site
  • Jilin
    • Changchun, Jilin, China
      • Research Site
  • Liaoning
    • Shenyang, Liaoning, China
      • Research Site
  • Neimeng
    • Huhehaote, Neimeng, China
      • Research Site
  • Shandong
    • Jinan, Shandong, China
      • Research Site
  • Shanghai
    • Shanghai, Shanghai, China
      • Research Site
  • Shanxi
    • Taiyuan, Shanxi, China
      • Research Site
    • Xian, Shanxi, China
      • Research Site
    • Yangquan, Shanxi, China
      • Research Site
  • Sichuan
    • Chengdu, Sichuan, China
      • Research Site
  • Tianjin
    • Tianjin, Tianjin, China
      • Research Site
  • Xinjiang
    • Wulumuqi, Xinjiang, China
      • Research Site
  • Yunnan
    • Kunming, Yunnan, China
      • Research Site
  • Zhejiang
    • Fuyang, Zhejiang, China
      • Research Site
    • Hangzhou, Zhejiang, China
      • Research Site
    • Jinhua, Zhejiang, China
      • Research Site
    • Wenzhou, Zhejiang, China
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized Patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Target subject population are the consecutive patients hospitalized due to peptic ulcer bleeding. Subjects should be: ≥18 years; admitted to the hospital with an overt upper GI bleed (hematemesis/coffee ground vomiting, melena, hematochezia and other clin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Zhaoshen Li, Changhai Hospital; Study Director: Karen Atkin, Astrazeneca China R&D

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: November 4, 2010
• First Submitted That Met QC Criteria: November 12, 2010
• First Posted (Estimate): November 16, 2010

Study Record Updates

• Last Update Posted (Estimate): December 30, 2011
• Last Update Submitted That Met QC Criteria: December 29, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: high risk; Peptic Ulcer Bleeding; None-Interventional Study; he proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb)
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Gastrointestinal Hemorrhage; Ulcer; Hemorrhage; Peptic Ulcer; Peptic Ulcer Hemorrhage
• Other Study ID Numbers: NIS-GCN-DUM-2010/1; D961DL00006