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Completed

NCT Number: NCT02245802

Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers

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

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Key information

Conditions

Bleeding Peptic Ulcer Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Hemorrhage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Combined Endoscopy Center, Prince of Wales Hospital

Hong Kong SAR, 00000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mortality difference between high risk and low risk group

    Time frame: 30 days

  2. Need of Surgery

    Time frame: 30 days

  3. Need of Transfusion

    Time frame: 30 days

    Need of transfusion as represented by number of units transfused

  4. Complication rate

    Time frame: 30 days

  5. Hospital stay

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Hiroshima City Asa Hospital, Hiroshima
  • Mitoyo General Hospital
  • National Taiwan University Hospital
  • Okayama University
  • Tokyo University
  • Tsuyama Central Hospital, Okayama

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 22, 2014
Registry last updated
Sep 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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