Bleeding Peptic UlcerNCT02245802
Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers
An observational study of Bleeding Peptic Ulcer, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
This study aimed to validate CU prediction model on mortality for patients with high risk bleeding peptic ulcers after therapeutic endoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding Peptic Ulcer
- How many people
- 785 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bleeding peptic ulcers who required endoscopic therapy
Who may be able to join
- Patients presented with bleeding peptic ulcers
- Age > 18 year old
- Informed consent for the study and OGD
Who cannot join
- Unable or refuse to give consent
- Onset more than 7 days
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
Combined Endoscopy Center, Prince of Wales Hospital
Hong Kong SAR, 00000
About this study
Official title: Multicenter Prospective Validation Study on the Prediction of In-hospital Mortality Using CU Prediction Model 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.
Read the 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.
- Conditions
- Bleeding Peptic Ulcer
- Keywords
- Bleeding peptic ulcer, Prediction model, Mortality, Prediction of in-hospital mortality for bleeding peptic ulcer
- Medical subject headings
- Peptic Ulcer Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low risk group | CU Prediction model < 3 | |
| High risk group | CU Prediction model >=3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (5)
Mortality difference between high risk and low risk group
Measured: 30 days
Need of Surgery
Measured: 30 days
Need of Transfusion
Need of transfusion as represented by number of units transfused
Measured: 30 days
Complication rate
Measured: 30 days
Hospital stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startAug 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bleeding Peptic UlcerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 785 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Tokyo University, National Taiwan University Hospital, Tsuyama Central Hospital, Okayama, Hiroshima City Asa Hospital, Hiroshima, Mitoyo General Hospital, Okayama University
- Responsible party
- Principal investigator, Philip Wai Yan Chiu, Chinese University of Hong Kong
- Investigators
- Philip Chiu, MD, Principal investigator, Department of Surgery, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245802
- Sponsor's protocol ID
- CRE-2010.207
- Status last verified
- Sep 2014
- First submitted
- 16 Sep 2014
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18955161
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Validation Study on the Prediction of In-hospital Mortality Using CU Prediction Model for Patients With Bleeding Peptic Ulcers
- ClinicalTrials.gov ID
- NCT02245802
- Acronym / sponsor ID
- CRE-2010.207
- Conditions
- Bleeding Peptic Ulcer
- Keywords
- Bleeding peptic ulcer, Prediction model, Mortality, Prediction of in-hospital mortality for bleeding peptic ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 785 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Tokyo University, National Taiwan University Hospital, Tsuyama Central Hospital, Okayama, Hiroshima City Asa Hospital, Hiroshima, Mitoyo General Hospital, Okayama University
- Study start
- Aug 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low risk group | – | –CU Prediction model < 3 |
| High risk group | – | –CU Prediction model >=3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bleeding peptic ulcers who required endoscopic therapy
Key inclusion criteria (3 listed)
- Patients presented with bleeding peptic ulcers
- Age > 18 year old
- Informed consent for the study and OGD
Key exclusion criteria (3 listed)
- Unable or refuse to give consent
- Onset more than 7 days
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
5 secondary outcomes
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
Complication rate
Time frame: 30 days
Hospital stay
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
- Background: PubMed 18955161Chiu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Chiu, MD principal investigator
Department of Surgery, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding Peptic Ulcer, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy in prediction of peptic ulcer bleeding related mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02245802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2014; AzTrials last refreshed its copy on 28 Oct 2026.