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NCT04211194 Clinical Trial

Registry for Upper Gastrointestinal Bleeding

Peptic Ulcer Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04211194
Other study ID # 1494617
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date January 31, 2021

Study information
Verified date February 2022
Source AdventHealth
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 2999
Est. completion date January 31, 2021
Est. primary completion date January 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Center for Interventional Endoscopy Orlando Florida

Sponsors (1)
Lead Sponsor Collaborator
AdventHealth

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Rate Mortality rate from upper gastrointestinal bleeding and from any etiology 30 days
Secondary Rate of Reintervention Need for repeat endoscopic treatment for upper gastrointestinal bleeding 30 days
Secondary Rate of Recurrence Recurrence of upper gastrointestinal bleeding following endoscopic treatment 30 days
Secondary Rate of Readmission Need for readmission to hospital for treatment of upper gastrointestinal bleeding 30 days
Secondary Length of hospital stay Length of hospitalization from index endoscopic procedure to discharge 30 days
Secondary Costs Total hospital costs from admission for upper gastrointestinal bleeding 30 days
Secondary Treatment success Successful treatment of upper gastrointestinal bleeding using endoscopic therapy as determined by a yes/no answer. 30 days
See also
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Completed NCT00164931 - A Study Comparing High Dose Omeprazole Infusion Against Scheduled Second Endoscopy for Bleeding Peptic Ulcer Phase 3
Completed NCT01241266 - China Survey of Peptic Ulcer Bleeding N/A
Completed NCT00037570 - Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage Phase 2
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Completed NCT05248321 - Precise Delivery of Tranexamic Acid to Enhance Endoscopic Hemostasis for Peptic Ulcer Bleeding N/A
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Not yet recruiting NCT06273384 - Diagnostic Performance of CIM for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding
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Completed NCT03163680 - Efficacy of Low Dose of Proton Pump Inhibitor in Treatment Bleeding Ulcers
Completed NCT00279123 - Effects of 2 Different Doses of Pantoprazole on Gastric pH and Recurrent Bleeding in Patients Who Bled From Peptic Ulcers Phase 4
Completed NCT03362268 - IIaprazole for the Treatment and Prevention of Peptic Ulcer Bleeding in Chinese Patients Phase 2
Completed NCT00573924 - Trial of Oral Versus Intravenous Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers N/A
Withdrawn NCT02724150 - Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding Phase 4
Active, not recruiting NCT04536428 - ClearEndoclip Versus EZ Clip for Upper Gastrointestinal Ulcer Bleeding N/A
Completed NCT02197039 - The Selection Criteria for the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers