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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02245802

Enrollment

785

Registered

2014-09-22

Start date

2010-08-31

Completion date

2012-04-30

Last updated

2014-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding Peptic Ulcer

Keywords

Bleeding peptic ulcer, Prediction model, Mortality, Prediction of in-hospital mortality for bleeding peptic ulcer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

China

Outcome results