Gastrointestinal HemorrhageNCT01031342
Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding
A study testing Early colonoscopy and Elective colonoscopy in people with Gastrointestinal Hemorrhage, run by University of Southern California at 1 site in United States.
Trial summary
Study hypothesis is that performing early colonoscopy in patients who present to the hospital with lower GI bleeding improves their outcome. Patients who are admitted with bleeding from their rectum and a negative endoscopic exam of the stomach and upper intestine are randomized (like flipping a coin) to receive a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage
- What is being tested?
- Early colonoscopy and Elective colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Nov 2009
- 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
- Patients who are admitted with rectal bleeding and one of the following high-risk features:
- HR > 100/min
- Systolic blood pressure <100 mmHg
- Orthostasis -considered as increase in HR by> 20/min on assuming erect position as well as by decrease by 20 mmHg in systolic blood pressure
- Need for blood transfusion
- Drop in hemoglobin > 1.5 g/dl or in hematocrit of > 6% in 6 hours
Who cannot join
- Inability to give informed consent
- Peritoneal signs
- Severe co-morbidities that would preclude the use of colonoscopy in standard clinical practice
Trial locations and contacts
1 site in 1 country.
United States1 site
L.A. County + U.S.C. Medical Center
Los Angeles, California, 90033
About this study
Official title: Early Versus Elective Colonoscopy in the Management of Lower Gastrointestinal Bleeding
Study hypothesis is that performing early colonoscopy in patients who present to the hospital with lower GI bleeding improves their outcome.
Patients who are admitted with bleeding from their rectum and a negative endoscopic exam of the stomach and upper intestine are randomized (like flipping a coin) to receive a colonsoscopy either as an emergency (within 12 hours) or as a routine procedure (36 hours after admission). Patients are followed during their hospitalization to see if they have further bleeding, if they require blood transfusions, if they need other diagnostic tests, if they need surgery or other treatments, and how long they stay in the hospital.
Read the detailed description
The aim of this study is to determine if performing early colonoscopy in patients who present to the hospital with lower GI bleeding improves their outcome.
Patients who are admitted with bleeding from their rectum and clinical evidence of a significant bleeding episode (elevated heart rate, low blood pressure, or need for blood transfusion) have immediate upper endoscopy (examination of the stomach with a flexible rubber tube with a light and video camera on the end). If this shows no source of bleeding, the patients are randomized (like flipping a coin) to receive a colonsoscopy (examination of the large intestine with a flexible rubber tube with a light and video camera on the end) either as a emergency (within 12 hours) or as a routine procedure (36 hours after admission).
Patients are followed during their hospitalization to see if they have further bleeding, if they require blood transfusions, if they need other diagnostic tests, if they need surgery or other treatments, and how long they stay in the hospital.
- Conditions
- Gastrointestinal Hemorrhage
- Being tested
- Early colonoscopy, Elective colonoscopy
- Keywords
- Colonoscopy, Gastrointestinal bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early colonoscopyProcedure or surgery
Colonoscopy within 12 hours of presentation
Elective colonoscopyProcedure or surgery
Colonoscopy 36-60 hours after presentation
| Study group | Role | What they receive |
|---|---|---|
| Early colonoscopy | Experimental | Colonoscopy performed within 12 hours of presentation Receives: Procedure: Early colonoscopy |
| Elective colonoscopy | Active comparator | Colonoscopy 36-60 hours after presentation Receives: Procedure: Elective colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Further bleeding
Measured: Duration of hospitalization (randomization to date of discharge from hospital)
Secondary outcomes (1)
Diagnostic yield
Measured: Duration of hospitalization (randomization to date of discharge from hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startAug 2002
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Change in ER rules (no longer allowed endoscopies in ER) prevented ability to perform study according to protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Investigators
- Loren Laine, M.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031342
- Sponsor's protocol ID
- HS-025014
- Status last verified
- Jan 2011
- First submitted
- 2 Nov 2009
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Elective Colonoscopy in the Management of Lower Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT01031342
- Acronym / sponsor ID
- HS-025014
- Conditions
- Gastrointestinal Hemorrhage
- Keywords
- Colonoscopy, Gastrointestinal bleeding
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in ER rules (no longer allowed endoscopies in ER) prevented ability to perform study according to protocol
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 14 Dec 2009 (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.
Study hypothesis is that performing early colonoscopy in patients who present to the hospital with lower GI bleeding improves their outcome.
Patients who are admitted with bleeding from their rectum and a negative endoscopic exam of the stomach and upper intestine are randomized (like flipping a coin) to receive a colonsoscopy either as an emergency (within 12 hours) or as a routine procedure (36 hours after admission). Patients are followed during their hospitalization to see if they have further bleeding, if they require blood transfusions, if they need other diagnostic tests, if they need surgery or other treatments, and how long they stay in the hospital.
Detailed description
The aim of this study is to determine if performing early colonoscopy in patients who present to the hospital with lower GI bleeding improves their outcome.
Patients who are admitted with bleeding from their rectum and clinical evidence of a significant bleeding episode (elevated heart rate, low blood pressure, or need for blood transfusion) have immediate upper endoscopy (examination of the stomach with a flexible rubber tube with a light and video camera on the end). If this shows no source of bleeding, the patients are randomized (like flipping a coin) to receive a colonsoscopy (examination of the large intestine with a flexible rubber tube with a light and video camera on the end) either as a emergency (within 12 hours) or as a routine procedure (36 hours after admission).
Patients are followed during their hospitalization to see if they have further bleeding, if they require blood transfusions, if they need other diagnostic tests, if they need surgery or other treatments, and how long they stay in the hospital.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early colonoscopy | Experimental | Procedure: Early colonoscopyColonoscopy performed within 12 hours of presentation |
| Elective colonoscopy | Active comparator | Procedure: Elective colonoscopyColonoscopy 36-60 hours after presentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who are admitted with rectal bleeding and one of the following high-risk features:
- HR > 100/min
- Systolic blood pressure <100 mmHg
- Orthostasis -considered as increase in HR by> 20/min on assuming erect position as well as by decrease by 20 mmHg in systolic blood pressure
- Need for blood transfusion
Key exclusion criteria (3 listed)
- Inability to give informed consent
- Peritoneal signs
- Severe co-morbidities that would preclude the use of colonoscopy in standard clinical practice
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 |
|---|---|---|
| Early colonoscopyColonoscopy within 12 hours of presentation | Procedure or surgery | Early colonoscopy |
| Elective colonoscopyColonoscopy 36-60 hours after presentation | Procedure or surgery | Elective colonoscopy |
Primary outcome
Further bleeding
Time frame: Duration of hospitalization (randomization to date of discharge from hospital)
1 secondary outcome
Diagnostic yield
Time frame: Duration of hospitalization (randomization to date of discharge from hospital)
Results and safety
The study was stopped early (reason given: Change in ER rules (no longer allowed endoscopies in ER) prevented ability to perform study according to protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2011.
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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, M.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early colonoscopy and Elective colonoscopy in people with Gastrointestinal Hemorrhage, run by University of Southern California 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 6 inclusion and 3 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 25 Jan 2011. 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: Change in ER rules (no longer allowed endoscopies in ER) prevented ability to perform study according to protocol). 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?
Further bleeding (time frame: Duration of hospitalization (randomization to date of discharge from hospital)). 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 25 Jan 2011.