NCT02152904

Brief Summary

The purpose of the investigators study is to investigate the factors associated with rebleeding in patients with peptic ulcer bleeding.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
892

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

May 29, 2014

Last Update Submit

August 3, 2016

Conditions

Peptic Ulcer Bleeding

Keywords

Peptic ulcer bleedingrebleedingmortalitynationwide

Outcome Measures

Primary Outcomes (1)

  • Rebleeding rate of peptic ulcer bleeding

    The rebleeding rate of patients diagnosed with peptic ulcer ble4eding

    1 year

Secondary Outcomes (1)

  • Mortality rates of peptic ulcer bleeding

    30 days

Study Arms (1)

Peptic ulcer bleeding patients

Endoscopy

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • Patients who refuse to be enrolled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Incheon St. Mary's Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal HemorrhageGastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Byung-Wook Kim, Ph.D.

    Incheon St. Mary's Hospital, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical assistant proffessor, Department of Internal medicine, Incheon St. Mary's Hospital

Study Record Dates

First Submitted

May 29, 2014

First Posted

June 2, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations

KR(1)