Peptic Ulcer BleedingKPUBNCT02152904
Risk Factors of Rebleeding After Peptic Ulcer Bleeding: a Nationwide Cohort Study
An observational study of Peptic Ulcer Bleeding, run by Joon Sung Kim at 1 site in South Korea.
Trial summary
The purpose of the investigators study is to investigate the factors associated with rebleeding in patients with peptic ulcer bleeding. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Peptic Ulcer Bleeding
- How many people
- 892 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Mar 2016
- How long will I take part?
- 1 Year
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visit the hospital with symptoms suggestive of peptic ulcer bleeding such as melena or hematemesis. These patients recieve endoscopy and when they are diagnosed with peptic ulcer bleeding are eligible for enrollment.
Who may be able to join
- Patients diagnosed with peptic ulcer bleeding by endoscopy
- Patients who consent to be enrolled in the study
Who cannot join
- Patients who refuse to be enrolled in the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the investigators study is to investigate the factors associated with rebleeding in patients with peptic ulcer bleeding.
Read the detailed description
The investigators are performing a nationwide population based cohort study to investigate the factors associated with rebleeding in patients with peptic ulcer bleeding. The results of the investigators study should give us information about patients who are at high risk of rebleeindg and enable us to manage these patients appropriately.
- Conditions
- Peptic Ulcer Bleeding
- Keywords
- Peptic ulcer bleeding, rebleeding, mortality, nationwide
- 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 |
|---|---|---|
| Peptic ulcer bleeding patients | Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding rate of peptic ulcer bleeding
The rebleeding rate of patients diagnosed with peptic ulcer ble4eding
Measured: 1 year
Secondary outcomes (1)
Mortality rates of peptic ulcer bleeding
The 30 day mortality rate of patients diagnosed with peptic ulcer bleeding
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 posted2 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer BleedingStudies of the same condition, open and under way.
- 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
- 892 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Joon Sung Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joon Sung Kim, Incheon St.Mary's Hospital
- Investigators
- Byung-Wook Kim, Ph.D., Principal investigator, Incheon St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152904
- Sponsor's protocol ID
- KPUB
- Acronym
- KPUB
- Status last verified
- Aug 2016
- First submitted
- 29 May 2014
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Rebleeding After Peptic Ulcer Bleeding: a Nationwide Cohort Study
- ClinicalTrials.gov ID
- NCT02152904
- Acronym / sponsor ID
- KPUB / KPUB
- Conditions
- Peptic Ulcer Bleeding
- Keywords
- Peptic ulcer bleeding, rebleeding, mortality, nationwide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 892 participants (actual)
- Lead sponsor
- Joon Sung KimUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Jun 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.
The purpose of the investigators study is to investigate the factors associated with rebleeding in patients with peptic ulcer bleeding.
Detailed description
The investigators are performing a nationwide population based cohort study to investigate the factors associated with rebleeding in patients with peptic ulcer bleeding. The results of the investigators study should give us information about patients who are at high risk of rebleeindg and enable us to manage these patients appropriately.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peptic ulcer bleeding patients | – | –Endoscopy |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visit the hospital with symptoms suggestive of peptic ulcer bleeding such as melena or hematemesis. These patients recieve endoscopy and when they are diagnosed with peptic ulcer bleeding are eligible for enrollment.
Key inclusion criteria (2 listed)
- Patients diagnosed with peptic ulcer bleeding by endoscopy
- Patients who consent to be enrolled in the study
Key exclusion criteria (1 listed)
- Patients who refuse to be enrolled in the study
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
Rebleeding rate of peptic ulcer bleeding
Time frame: 1 year
The rebleeding rate of patients diagnosed with peptic ulcer ble4eding
1 secondary outcome
Mortality rates of peptic ulcer bleeding
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 4 Aug 2016.
Related trials for Peptic Ulcer Bleeding
RecruitingPhase 4
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
Coronary Artery Disease, Percutaneous Coronary Intervention
RecruitingPhase 2
Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers
Peptic Ulcer Bleeding
Not yet recruiting
Potassium-competitive Acid Blocker Versus Double Dose Proton Pump Inhibitors in High High-risk Peptic Ulcer Bleeding
Bleeding
Recruiting
Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
Roux-en-y Anastomosis Site, Marginal Ulcer
Recruiting
Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding
Acute Gastrointestinal Bleeding
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.
Byung-Wook Kim, Ph.D. principal investigator
Incheon St. Mary's Hospital, The Catholic University of Korea
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 Peptic Ulcer Bleeding, run by Joon Sung Kim at 1 site in South Korea.
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 2 inclusion and 1 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 4 Aug 2016. 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 South Korea. 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?
Rebleeding rate of peptic ulcer bleeding (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2016.