Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers

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

Detailed Description
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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.

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

Conditions
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Bleeding Peptic Ulcer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presented with bleeding peptic ulcers Age > 18 year old Informed consent for the study and OGD Exclusion Criteria: Unable or refuse to give consent Onset more than 7 days Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low risk group<br>CU Prediction model < 3 | |
| High risk group<br>CU Prediction model >=3 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality difference between high risk and low risk group |  | 30 days | 
| Need of Surgery |  | 30 days | 
| Need of Transfusion | Need of transfusion as represented by number of units transfused | 30 days | 
| Complication rate |  | 30 days | 
| Hospital stay |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bleeding peptic ulcer, Prediction model, Mortality, Prediction of in-hospital mortality for bleeding peptic ulcer