China Survey of Peptic Ulcer Bleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1044 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-07-31

Brief Summary

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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 Description

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Conditions

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Peptic Ulcer Hemorrhage

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Atkin

Role: STUDY_DIRECTOR

Astrazeneca China R&D

Zhaoshen Li

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

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D961DL00006

Identifier Type: -

Identifier Source: secondary_id

NIS-GCN-DUM-2010/1

Identifier Type: -

Identifier Source: org_study_id

China Survey of Peptic Ulcer Bleeding

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

1

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

AstraZeneca

Responsible Party

Principal Investigators

Karen Atkin

Zhaoshen Li

Locations

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Countries

Other Identifiers

D961DL00006

NIS-GCN-DUM-2010/1