Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers

Bleeding Peptic Ulcer Clinical Trial

Official title:

Multicenter Prospective Validation Study on the Prediction of In-hospital Mortality Using CU Prediction Model for Patients With Bleeding Peptic Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245802
• Other study ID #: CRE-2010.207
• Status: Completed
• Phase: N/A
• First received: September 16, 2014
• Last updated: September 19, 2014
• Start date: August 2010
• Est. completion date: April 2012

Study information

• Verified date: September 2014
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Chinese University of Hong Kong
• Study type: Observational

Clinical Trial Summary

This study aimed to validate CU prediction model on mortality for patients with high risk bleeding peptic ulcers after therapeutic endoscopy.

Description:

Despite advances in management of patients with bleeding peptic ulcers, mortality is still 10%. We previously reported a prediction score for ulcer bleeding related mortality developed from a local cohort. The risk factors for mortality included patients older than 70, presence of co-morbidity, more than one listed co-morbidity, hematemesis, SBP < 100 mmHg, in-hospital bleeding, rebleeding, and need for surgery.

Study objective This study aimed to validate the prediction of mortality among patients with bleeding peptic ulcers from different Asian countries.

Method Consecutive patients with bleeding peptic ulcers who presented to the study centers in Hong Kong, Japan and Taiwan were recruited after successful primary endoscopic hemostasis. The baseline demographics, ulcer characteristics, the predictive factors, 30 days mortality, rebleeding, hospital stay and need of surgery were recorded. The accuracy of prediction for adverse events including mortality and rebleeding with the prediction risk scoring system would be analysed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 785
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients presented with bleeding peptic ulcers

2. Age > 18 year old

3. Informed consent for the study and OGD

Exclusion Criteria:

1. Unable or refuse to give consent

2. Onset more than 7 days

3. Pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bleeding Peptic Ulcer
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Locations

Country	Name	City	State
China	Combined Endoscopy Center, Prince of Wales Hospital	Hong Kong SAR

Sponsors (7)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Hiroshima City Asa Hospital, Hiroshima, Mitoyo General Hospital, National Taiwan University Hospital, Okayama University, Tokyo University, Tsuyama Central Hospital, Okayama

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mortality difference between high risk and low risk group		30 days	No
Secondary	Need of Surgery		30 days	No
Secondary	Need of Transfusion	Need of transfusion as represented by number of units transfused	30 days	No
Secondary	Complication rate		30 days	No
Secondary	Hospital stay		30 days	No