China Survey of Peptic Ulcer Bleeding

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01241266

Acronym

PUB

Enrollment

1044

Registered

2010-11-16

Start date

2010-11-30

Completion date

2011-07-31

Last updated

2011-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic Ulcer Hemorrhage

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results