Risk Factors of Rebleeding After Peptic Ulcer Bleeding: a... | NCT02152904

Studies
Risk Factors of Rebleeding After Peptic Ulcer Bleeding: a Nationwide Cohort Study

NCT02152904

Sponsor

Joon Sung Kim

Status

Completed

Last Update Posted

Aug 4, 2016Estimated

Enrollment

892Actual

Phase

Not provided

Conditions

Peptic Ulcer Bleeding

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Mar 2016Actual

First Submitted Date

May 29, 2014

First Submission Date that Met QC Criteria

May 30, 2014

First Posted Date

Jun 2, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2016

Last Update Posted Date

Aug 4, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joon Sung Kim, Clinical assistant proffessor, Department of Internal medicine, Incheon St. Mary's Hospital, Incheon St.Mary's HospitalSponsor-Investigator

Lead Sponsor

Joon Sung KimOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

892Actual

Label	Type	Description	Intervention Names
Peptic ulcer bleeding patients		Endoscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rebleeding rate of peptic ulcer bleeding	The rebleeding rate of patients diagnosed with peptic ulcer ble4eding	1 year

Secondary Outcomes

Measure	Description	Time Frame
Mortality rates of peptic ulcer bleeding	The 30 day mortality rate of patients diagnosed with peptic ulcer bleeding	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with peptic ulcer bleeding by endoscopy
Patients who consent to be enrolled in the study

Exclusion Criteria:

Patients who refuse to be enrolled in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Byung-Wook Kim, Ph.D.	Incheon St. Mary's Hospital, The Catholic University of Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Incheon St. Mary's Hospital		Incheon			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D010438	Peptic Ulcer Hemorrhage

Ancestor Terms

ID	Term
D006471	Gastrointestinal Hemorrhage
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage

Browse Leaves

Not provided

Browse Branches

Not provided