Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers

Completed

• Conditions: Bleeding Peptic Ulcer

• Registration Number: NCT02245802
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2014-09
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-19
• Last Update Submitted: 2014-09-19
• Study First Posted: 2014-09-22
• Last Update Posted: 2014-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 785

Inclusion Criteria

1. Patients presented with bleeding peptic ulcers
2. Age > 18 year old
3. Informed consent for the study and OGD

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Exclusion Criteria

1. Unable or refuse to give consent
2. Onset more than 7 days
3. Pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy in prediction of peptic ulcer bleeding related mortality	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Complication rate	30 days
Hospital stay	30 days
Mortality difference between high risk and low risk group	30 days
Need of Transfusion	30 days	Need of transfusion as represented by number of units transfused
Need of Surgery	30 days

Trial Locations

Locations (1)

Combined Endoscopy Center, Prince of Wales Hospital; 🇨🇳 Hong Kong SAR, China