NCT04211194

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,999

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

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

October 1, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

October 30, 2019

Last Update Submit

February 15, 2022

Conditions

Peptic Ulcer HemorrhagePeptic Ulcer, Acute With Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Mortality Rate

    Mortality rate from upper gastrointestinal bleeding and from any etiology

    30 days

Secondary Outcomes (6)

  • Rate of Reintervention

    30 days

  • Rate of Recurrence

    30 days

  • Rate of Readmission

    30 days

  • Length of hospital stay

    30 days

  • Costs

    30 days

  • +1 more secondary outcomes

Study Arms (1)

Patients with upper gastrointestinal bleeding

Patients with upper gastrointestinal bleeding undergoing endoscopic procedures at AdventHealth Hospitals in Central Florida

Procedure: Upper GI Endoscopy

Interventions

Upper GI EndoscopyPROCEDURE

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.

Patients with upper gastrointestinal bleeding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Interventional Endoscopy

Orlando, Florida, 32803, United States

Location

MeSH Terms

Conditions

Peptic Ulcer HemorrhagePeptic Ulcer

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Gastrointestinal HemorrhageGastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsDuodenal DiseasesIntestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Shyam Varadarajulu, MD

    AdventHealth Orlando

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2019

First Posted

December 26, 2019

Study Start

October 1, 2019

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

February 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)