Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers
Multicenter Prospective Validation Study on the Prediction of In-hospital Mortality Using CU Prediction Model for Patients With Bleeding Peptic Ulcers
1 other identifier
observational
785
1 country
1
Brief Summary
This study aimed to validate CU prediction model on mortality for patients with high risk bleeding peptic ulcers after therapeutic endoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 16, 2014
CompletedFirst Posted
Study publicly available on registry
September 22, 2014
CompletedSeptember 22, 2014
September 1, 2014
1.7 years
September 16, 2014
September 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy in prediction of peptic ulcer bleeding related mortality
The CU prediction score would be calculated from addition of all the risk factors scores. . The calculated predictive score collected from the whole group of patients would be analyzed using the receiver operating characteristic (ROC) curve and represented using the area under curve (AUC). An AUC of 0.5 would be interpreted as poor predictive power whereas a value of 1.0 would indicate excellent predictive power.
30 days
Secondary Outcomes (5)
Mortality difference between high risk and low risk group
30 days
Need of Surgery
30 days
Need of Transfusion
30 days
Complication rate
30 days
Hospital stay
30 days
Study Arms (2)
Low risk group
CU Prediction model \< 3
High risk group
CU Prediction model \>=3
Eligibility Criteria
Patients with bleeding peptic ulcers who required endoscopic therapy
You may qualify if:
- Patients presented with bleeding peptic ulcers
- Age \> 18 year old
- Informed consent for the study and OGD
You may not qualify if:
- Unable or refuse to give consent
- Onset more than 7 days
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese University of Hong Konglead
- Tokyo Universitycollaborator
- National Taiwan University Hospitalcollaborator
- Tsuyama Central Hospital, Okayamacollaborator
- Hiroshima City Asa Hospital, Hiroshimacollaborator
- Mitoyo General Hospitalcollaborator
- Okayama Universitycollaborator
Study Sites (1)
Combined Endoscopy Center, Prince of Wales Hospital
Hong Kong SAR, 00000, China
Related Publications (1)
Chiu PW, Ng EK, Cheung FK, Chan FK, Leung WK, Wu JC, Wong VW, Yung MY, Tsoi K, Lau JY, Sung JJ, Chung SS. Predicting mortality in patients with bleeding peptic ulcers after therapeutic endoscopy. Clin Gastroenterol Hepatol. 2009 Mar;7(3):311-6; quiz 253. doi: 10.1016/j.cgh.2008.08.044. Epub 2008 Sep 13.
PMID: 18955161BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Chiu, MD
Department of Surgery, The Chinese University of Hong Kong
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Surgery, Institute of Digestive Disease
Study Record Dates
First Submitted
September 16, 2014
First Posted
September 22, 2014
Study Start
August 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
September 22, 2014
Record last verified: 2014-09