China Survey of Peptic Ulcer Bleeding
PUB
2 other identifiers
observational
1,044
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2010
Shorter than P25 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 4, 2010
CompletedFirst Posted
Study publicly available on registry
November 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedDecember 30, 2011
December 1, 2011
8 months
November 4, 2010
December 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb).
1 day
Secondary Outcomes (3)
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
Study Arms (1)
1
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
Eligibility Criteria
Hospitalized Patients
You may qualify if:
- 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)
You may not qualify if:
- If participating in any clinical trial, the subject cannot take part in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (31)
Research Site
Hefei, Anhui, China
Research Site
Beijing, Beijing Municipality, China
Research Site
Chongqing, Chongqing Municipality, China
Research Site
Fuzhou, Fujian, China
Research Site
Xiamen, Fujian, China
Research Site
Lanzhou, Gansu, China
Research Site
Guangzhou, Guangdong, China
Research Site
Shenzhen, Guangdong, China
Research Site
Haerbin, Heilongjiang, China
Research Site
Wuhan, Hubei, China
Research Site
Changsha, Hunan, China
Research Site
Jiangyin, Jiangsu, China
Research Site
Nanjing, Jiangsu, China
Research Site
Nantong, Jiangsu, China
Research Site
Nanchang, Jiangxi, China
Research Site
Changchun, Jilin, China
Research Site
Shenyang, Liaoning, China
Research Site
Hohhot, Neimeng, China
Research Site
Jinan, Shandong, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Taiyuan, Shanxi, China
Research Site
Xian, Shanxi, China
Research Site
Yangquan, Shanxi, China
Research Site
Chengdu, Sichuan, China
Research Site
Tianjin, Tianjin Municipality, China
Research Site
Ürümqi, Xinjiang, China
Research Site
Kunming, Yunnan, China
Research Site
Fuyang, Zhejiang, China
Research Site
Hangzhou, Zhejiang, China
Research Site
Jinhua, Zhejiang, China
Research Site
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karen Atkin
Astrazeneca China R&D
- PRINCIPAL INVESTIGATOR
Zhaoshen Li
Changhai Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2010
First Posted
November 16, 2010
Study Start
November 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
December 30, 2011
Record last verified: 2011-12