Peptic Ulcer HemorrhageNCT04211194
Registry for Upper Gastrointestinal Bleeding
An observational study of Peptic Ulcer Hemorrhage and Peptic Ulcer, Acute With Hemorrhage, run by AdventHealth at 1 site in United States.
Trial summary
This project aims to evaluate the data on all patients undergoing endoscopic therapy for upper gastrointestinal bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer Hemorrhage, Peptic Ulcer, Acute With Hemorrhage
- What is being tested?
- Upper GI Endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 2,999 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will come from patient who are undergoing endoscopic treatment for upper gastrointestinal bleeding at AdventHealth Hospitals.
Who may be able to join
- Patient is 18 years of age or greater
- Patient is undergoing endoscopic treatment for upper gastrointestinal bleeding
Who cannot join
- Under the age of 18
- Patient not undergoing endoscopic treatment for upper gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interventional Endoscopy
Orlando, Florida, 32803
About this study
Official title: 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.
Read the 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.
- Being tested
- Upper GI Endoscopy
- Medical subject headings
- Peptic Ulcer Hemorrhage, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper GI EndoscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with upper gastrointestinal bleeding | Patients with upper gastrointestinal bleeding undergoing endoscopic procedures at AdventHealth Hospitals in Central Florida Receives: Procedure: Upper GI Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate
Mortality rate from upper gastrointestinal bleeding and from any etiology
Measured: 30 days
Secondary outcomes (6)
Rate of Reintervention
Need for repeat endoscopic treatment for upper gastrointestinal bleeding
Measured: 30 days
Rate of Recurrence
Recurrence of upper gastrointestinal bleeding following endoscopic treatment
Measured: 30 days
Rate of Readmission
Need for readmission to hospital for treatment of upper gastrointestinal bleeding
Measured: 30 days
Length of hospital stay
Length of hospitalization from index endoscopic procedure to discharge
Measured: 30 days
Costs
Total hospital costs from admission for upper gastrointestinal bleeding
Measured: 30 days
Treatment success
Successful treatment of upper gastrointestinal bleeding using endoscopic therapy as determined by a yes/no answer.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Oct 2019
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,999 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyam Varadarajulu, MD, Principal investigator, AdventHealth Orlando
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211194
- Sponsor's protocol ID
- 1494617
- Status last verified
- Feb 2022
- First submitted
- 30 Oct 2019
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Orange County Bleeding Consortium (OCBC): Registry of Patients Undergoing Endoscopic Procedures for Upper Gastrointestinal Bleeding in AdventHealth Hospitals in Central Florida
- ClinicalTrials.gov ID
- NCT04211194
- Acronym / sponsor ID
- 1494617
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,999 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to evaluate the data on all patients undergoing endoscopic therapy for upper gastrointestinal bleeding.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with upper gastrointestinal bleeding | – | Procedure: Upper GI EndoscopyPatients with upper gastrointestinal bleeding undergoing endoscopic procedures at AdventHealth Hospitals in Central Florida |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will come from patient who are undergoing endoscopic treatment for upper gastrointestinal bleeding at AdventHealth Hospitals.
Key inclusion criteria (2 listed)
- Patient is 18 years of age or greater
- Patient is undergoing endoscopic treatment for upper gastrointestinal bleeding
Key exclusion criteria (2 listed)
- Under the age of 18
- Patient not undergoing endoscopic treatment for upper gastrointestinal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper GI EndoscopyPatients 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. | Procedure or surgery | Patients with upper gastrointestinal bleeding |
Primary outcome
Mortality Rate
Time frame: 30 days
Mortality rate from upper gastrointestinal bleeding and from any etiology
6 secondary outcomes
Rate of Reintervention
Time frame: 30 days
Rate of Recurrence
Time frame: 30 days
Rate of Readmission
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
Costs
Time frame: 30 days
Treatment success
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shyam Varadarajulu, MD principal investigator
AdventHealth Orlando
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peptic Ulcer Hemorrhage and Peptic Ulcer, Acute With Hemorrhage, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality Rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.