Clinical Trial: Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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

Detailed Summary:

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.


Sponsor: Chinese University of Hong Kong

Current Primary Outcome: Accuracy in prediction of peptic ulcer bleeding related mortality [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mortality difference between high risk and low risk group [ Time Frame: 30 days ]
  • Need of Surgery [ Time Frame: 30 days ]
  • Need of Transfusion [ Time Frame: 30 days ]
    Need of transfusion as represented by number of units transfused
  • Complication rate [ Time Frame: 30 days ]
  • Hospital stay [ Time Frame: 30 days ]


Original Secondary Outcome: Same as current

Information By: Chinese University of Hong Kong

Dates:
Date Received: September 16, 2014
Date Started: August 2010
Date Completion:
Last Updated: September 19, 2014
Last Verified: September 2014