Clinical trial NCT02245802: Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers
Official title: Multicenter Prospective Validation Study on the Prediction of In-hospital Mortality Using CU Prediction Model for Patients With Bleeding Peptic Ulcers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding Peptic Ulcer
Keywords: Bleeding peptic ulcer
Prediction model
Mortality
Prediction of in-hospital mortality for bleeding peptic ulcer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Tokyo University
name: National Taiwan University Hospital
name: Tsuyama Central Hospital, Okayama
name: Hiroshima City Asa Hospital, Hiroshima
name: Mitoyo General Hospital
name: Okayama University
First posted: 2014-09-22
Enrollment: 785
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bleeding peptic ulcers who required endoscopic therapy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy in prediction of peptic ulcer bleeding related mortality
timeFrame: 30 days
Secondary outcomes:
measure: Mortality difference between high risk and low risk group
timeFrame: 30 days
measure: Need of Surgery
timeFrame: 30 days
measure: Need of Transfusion
timeFrame: 30 days
measure: Complication rate
timeFrame: 30 days
measure: Hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: Combined Endoscopy Center, Prince of Wales Hospital
Study officials:
affiliation: Department of Surgery, The Chinese University of Hong Kong
name: Philip Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiu PW, Ng EK, Cheung FK, Chan FK, Leung WK, Wu JC, Wong VW, Yung MY, Tsoi K, Lau JY, Sung JJ, Chung SS. Predicting mortality in patients with bleeding peptic ulcers after therapeutic endoscopy. Clin Gastroenterol Hepatol. 2009 Mar;7(3):311-6; quiz 253. doi: 10.1016/j.cgh.2008.08.044. Epub 2008 Sep 13.