Clinical Trial: China Survey of Peptic Ulcer Bleeding

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: China Survey of Peptic Ulcer Bleeding

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 Summary:
Sponsor: AstraZeneca

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: AstraZeneca

Dates:
Date Received: November 4, 2010
Date Started: November 2010
Date Completion:
Last Updated: December 29, 2011
Last Verified: December 2011