Clinical trial NCT01241266: China Survey of Peptic Ulcer Bleeding
Official title: China Survey of Peptic Ulcer Bleeding
Study type: OBSERVATIONAL
Overall status: COMPLETED
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)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 1044
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized Patients

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb).
timeFrame: 1 day
Secondary outcomes:
measure: The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb) and receiving endoscopic treatment
timeFrame: 1 day
measure: The proportion of patients receiving endoscopic treatments by type of endoscopic treatmentendoscopic treatment
timeFrame: 5 day
measure: 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.
timeFrame: 30 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: Research Site
state: Anhui
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Chongqing
country: China
facility: Research Site
state: Chongqing
city: Fuzhou
country: China
facility: Research Site
state: Fujian
city: Xiamen
country: China
facility: Research Site
state: Fujian
city: Lanzhou
country: China
facility: Research Site
state: Gansu
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Shenzhen
country: China
facility: Research Site
state: Guangdong
city: Haerbin
country: China
facility: Research Site
state: Heilongjiang
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Jiangyin
country: China
facility: Research Site
state: Jiangsu
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Nantong
country: China
facility: Research Site
state: Jiangsu
city: Nanchang
country: China
facility: Research Site
state: Jiangxi
city: Changchun
country: China
facility: Research Site
state: Jilin
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: Huhehaote
country: China
facility: Research Site
state: Neimeng
city: Jinan
country: China
facility: Research Site
state: Shandong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Taiyuan
country: China
facility: Research Site
state: Shanxi
city: Xian
country: China
facility: Research Site
state: Shanxi
city: Yangquan
country: China
facility: Research Site
state: Shanxi
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Wulumuqi
country: China
facility: Research Site
state: Xinjiang
city: Kunming
country: China
facility: Research Site
state: Yunnan
city: Fuyang
country: China
facility: Research Site
state: Zhejiang
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Jinhua
country: China
facility: Research Site
state: Zhejiang
city: Wenzhou
country: China
facility: Research Site
state: Zhejiang
Study officials:
affiliation: Astrazeneca China R&D
name: Karen Atkin
role: STUDY_DIRECTOR
affiliation: Changhai Hospital
name: Zhaoshen Li
role: PRINCIPAL_INVESTIGATOR
References: