China Survey of Peptic Ulcer Bleeding (PUB)

AstraZeneca

Status: Completed

Conditions: Peptic Ulcer Hemorrhage

Study type: Observational

Funder types: Industry

Identifiers

NCT01241266

D961DL00006

NIS-GCN-DUM-2010/1

Details and patient eligibility

About

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.

Enrollment: 1,044 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,044 participants in 1 patient group

1

Description:

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