Upper Gastrointestinal BleedingNCT02005705
Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.
A study testing Outpatient Management of Low-risk Patients and Inpatient Management of Low-risk Patients in people with Upper Gastrointestinal Bleeding, run by Yale University at 1 site in United States.
Trial summary
Patients presenting to the emergency room with upper gastrointestinal bleeding and a Glasgow Blatchford score of zero will be randomly assigned to further care in the inpatient vs. outpatient setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- Outpatient Management of Low-risk Patients and Inpatient Management of Low-risk Patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jun 2016
- Phase
- Interventional
- 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
Who may be able to join
- Blood Urea Nitrogen < 18.2 mg/dl
- Hemoglobin ≥ 13.0 g/dl for men and ≥ 12.0 g/dl for women
- Systolic blood pressure ≥ 110 mm Hg
- Heart rate < 100 beats/min
Who cannot join
- Inability to obtain informed consent
- Pregnancy
- History of liver disease
- History of heart failure
- Syncope that is temporally related to ongoing bleeding
- Melena
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- Contraindication to proton pump inhibitor use
- Other conditions that necessitate inpatient evaluation.
- Inpatients with new onset of GI bleeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Patients presenting to the emergency room with upper gastrointestinal bleeding and a Glasgow Blatchford score of zero will be randomly assigned to further care in the inpatient vs. outpatient setting. The hypothesis of this study is that patients who are managed as outpatients will require interventions at a rate not higher than those managed as inpatients and will have lower direct healthcare costs.
- Conditions
- Upper Gastrointestinal Bleeding
- Being tested
- Outpatient Management of Low-risk Patients, Inpatient Management of Low-risk Patients
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient Management of Low-risk PatientsOther
- Labs will be obtained within 2-3 days of discharge from ED
- Clinic visit will be scheduled within 3 days of discharge from ED
- EGD will be scheduled within 7 days of discharge from ED
- Phone follow-up at day 7 and 30
Inpatient Management of Low-risk PatientsOther
- Labs will be obtained on day of discharge or day 2-3
- EGD will be performed in the hospital
- Phone follow-up at day 7 and 30
| Study group | Role | What they receive |
|---|---|---|
| Outpatient | Active comparator | Not described Receives: Other: Outpatient Management of Low-risk Patients |
| Inpatient | Active comparator | Not described Receives: Other: Inpatient Management of Low-risk Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients requiring intervention for UGIB (endoscopic therapy, blood transfusion, surgery, interventional radiology)
Measured: Within 7 days of the index presentation to the emergency room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loren Laine, Yale University
- Investigators
- Loren Laine, MD, Principal investigator, Yale University, Section of Digestive Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005705
- Sponsor's protocol ID
- HIC 1307012373
- Status last verified
- Jul 2016
- First submitted
- 3 Dec 2013
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.
- ClinicalTrials.gov ID
- NCT02005705
- Acronym / sponsor ID
- HIC 1307012373
- Conditions
- Upper Gastrointestinal Bleeding
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Dec 2013 (estimated)
- 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.
Patients presenting to the emergency room with upper gastrointestinal bleeding and a Glasgow Blatchford score of zero will be randomly assigned to further care in the inpatient vs. outpatient setting. The hypothesis of this study is that patients who are managed as outpatients will require interventions at a rate not higher than those managed as inpatients and will have lower direct healthcare costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient | Active comparator | Other: Outpatient Management of Low-risk Patients |
| Inpatient | Active comparator | Other: Inpatient Management of Low-risk Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Blood Urea Nitrogen < 18.2 mg/dl
- Hemoglobin ≥ 13.0 g/dl for men and ≥ 12.0 g/dl for women
- Systolic blood pressure ≥ 110 mm Hg
- Heart rate < 100 beats/min
Key exclusion criteria (9 listed)
- Inability to obtain informed consent
- Pregnancy
- History of liver disease
- History of heart failure
- Syncope that is temporally related to ongoing 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 |
|---|---|---|
| Outpatient Management of Low-risk Patients* Labs will be obtained within 2-3 days of discharge from ED * Clinic visit will be scheduled within 3 days of discharge from ED * EGD will be scheduled within 7 days of discharge from ED * Phone follow-up at day 7 and 30 | Other | Outpatient |
| Inpatient Management of Low-risk Patients* Labs will be obtained on day of discharge or day 2-3 * EGD will be performed in the hospital * Phone follow-up at day 7 and 30 | Other | Inpatient |
Primary outcome
The number of patients requiring intervention for UGIB (endoscopic therapy, blood transfusion, surgery, interventional radiology)
Time frame: Within 7 days of the index presentation to the emergency room
Results and safety
The study was stopped early (reason given: Inadequate recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
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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.
Loren Laine, MD principal investigator
Yale University, Section of Digestive Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient Management of Low-risk Patients and Inpatient Management of Low-risk Patients in people with Upper Gastrointestinal Bleeding, run by Yale University 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Jul 2016. 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 was stopped early (reason given: Inadequate recruitment). Results are not available in the source record.
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?
The number of patients requiring intervention for UGIB (endoscopic therapy, blood transfusion, surgery, interventional radiology) (time frame: Within 7 days of the index presentation to the emergency room). 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 14 Jul 2016.