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NCT Number: NCT01241266

China Survey of Peptic Ulcer Bleeding

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 1 day

Secondary outcomes

  1. The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb) and receiving endoscopic treatment

    Time frame: 1 day

  2. The proportion of patients receiving endoscopic treatments by type of endoscopic treatmentendoscopic treatment

    Time frame: 5 day

  3. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: PUB

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 16, 2010
Registry last updated
Dec 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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