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China Survey of Peptic Ulcer Bleeding (PUB)

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: November 4, 2010
Last updated: December 29, 2011
Last verified: December 2011
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.

Peptic Ulcer Hemorrhage

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: China Survey of Peptic Ulcer Bleeding

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb). [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb) and receiving endoscopic treatment [ Time Frame: 1 day ]
  • The proportion of patients receiving endoscopic treatments by type of endoscopic treatmentendoscopic treatment [ Time Frame: 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. [ Time Frame: 30 days ]

Enrollment: 1044
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized Patients

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01241266

  Show 31 Study Locations
Sponsors and Collaborators
Study Director: Karen Atkin Astrazeneca China R&D
Principal Investigator: Zhaoshen Li Changhai Hospital
  More Information

Responsible Party: AstraZeneca Identifier: NCT01241266     History of Changes
Other Study ID Numbers: NIS-GCN-DUM-2010/1
Study First Received: November 4, 2010
Last Updated: December 29, 2011

Keywords provided by AstraZeneca:
Peptic Ulcer Bleeding
high risk
None-Interventional Study
he proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb)

Additional relevant MeSH terms:
Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage processed this record on May 25, 2017