Registry for Upper Gastrointestinal Bleeding

February 15, 2022 updated by: AdventHealth

The Orange County Bleeding Consortium (OCBC): Registry of Patients Undergoing Endoscopic Procedures for Upper Gastrointestinal Bleeding in AdventHealth Hospitals in Central Florida

This project aims to evaluate the data on all patients undergoing endoscopic therapy for upper gastrointestinal bleeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project is being performed to evaluate the outcomes of patients undergoing endoscopic procedures for upper gastrointestinal bleeding at all AdventHealth hospitals in Central Florida. This information will enable quality control of patients undergoing treatment for upper gastrointestinal bleeding across all campuses in the AdventHealth system in Central Florida and hence improve the delivery ot care extended to the investigator's patients.

Study Type

Observational

Enrollment (Actual)

2999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
        • Center for Interventional Endoscopy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population will come from patient who are undergoing endoscopic treatment for upper gastrointestinal bleeding at AdventHealth Hospitals.

Description

Inclusion Criteria:

  • Patient is 18 years of age or greater
  • Patient is undergoing endoscopic treatment for upper gastrointestinal bleeding

Exclusion Criteria:

  • Under the age of 18
  • Patient not undergoing endoscopic treatment for upper gastrointestinal bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with upper gastrointestinal bleeding
Patients with upper gastrointestinal bleeding undergoing endoscopic procedures at AdventHealth Hospitals in Central Florida
Procedure: Upper GI Endoscopy
Patients with upper gastrointestinal bleeding undergoing endoscopic therapy. Information regarding the need for interventional radiology procedures or surgical interventions will also be collected in patients in whom endoscopic therapy is not successful.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality Rate
Time Frame: 30 days
Mortality rate from upper gastrointestinal bleeding and from any etiology
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Reintervention
Time Frame: 30 days
Need for repeat endoscopic treatment for upper gastrointestinal bleeding
30 days
Rate of Recurrence
Time Frame: 30 days
Recurrence of upper gastrointestinal bleeding following endoscopic treatment
30 days
Rate of Readmission
Time Frame: 30 days
Need for readmission to hospital for treatment of upper gastrointestinal bleeding
30 days
Length of hospital stay
Time Frame: 30 days
Length of hospitalization from index endoscopic procedure to discharge
30 days
Costs
Time Frame: 30 days
Total hospital costs from admission for upper gastrointestinal bleeding
30 days
Treatment success
Time Frame: 30 days
Successful treatment of upper gastrointestinal bleeding using endoscopic therapy as determined by a yes/no answer.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2019

Primary Completion (ACTUAL)

January 31, 2021

Study Completion (ACTUAL)

January 31, 2021

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

December 23, 2019

First Posted (ACTUAL)

December 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1494617

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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