Bleeding Peptic UlcerNCT01675856
Urgent vs. Early Endoscopy in High Risk Patients With Upper Gastrointestinal Bleeding (UGIB)
A study testing Urgent endoscopy and Early endoscopy in people with Bleeding Peptic Ulcer and Active Bleeding, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Acute upper gastrointestinal bleeding (UGIB) is one of the commonest medical emergencies. The condition accounts for 150 per 100,000 populations. A National United Kingdom reported a crude overall mortality rate of 10%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding Peptic Ulcer, Active Bleeding, Gastrointestinal Bleeding
- What is being tested?
- Urgent endoscopy and Early endoscopy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 516 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2012to 11 Nov 2018
- 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
- Overt signs of upper gastrointestinal bleeding (i.e., melena or hematemesis with or without hypotension)
- GBS of ≥12
- In-patients admitted for reasons other than AUGIB who develop bleeding are also considered for trial enrollment.
- Patients in Hypotensive shock (SBP ≤90 mmHg or pulse ≥110 bpm) are initially resuscitated and then considered for trial entry if their condition can be stabilized.
Who cannot join
- continued shock despite initial volume resuscitation (refractory shock) undergo urgent endoscopy
- < 18 years of age
- Unable to provide written informed consent
- Pregnant or lactating women
- Moribund patients from terminal illnesses. (active treatment not considered)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urgent vs. Early Endoscopy in High Risk Patients With UGIB
Acute upper gastrointestinal bleeding (UGIB) is one of the commonest medical emergencies. The condition accounts for 150 per 100,000 populations. A National United Kingdom reported a crude overall mortality rate of 10%. While bleeding stops spontaneously in majority of patients at their presentation, there remains a subgroup of patients who continue to bleed or develop recurrent bleeding. In these patients, the mortality increases manifolds. If these high-risk patients can be identified, early interventions may improve their outcomes.
Several prognostic indices are in use for the purpose of patient stratification. They include the Rockall, Glasgow-Blatchford (GBS) and the Baylor scores. The Rockall score is a composite score which incorporates clinical parameters as well as findings during endoscopy which was derived to predict mortality. The GBS is a pre-endoscopy or a clinical score for the prediction for the need of further intervention loosely defined as the need for transfusion, endoscopy or surgery. It has been shown to be accurate in identifying low risk patients for early discharge.
Read the detailed description
The GBS, being a pre-endoscopy score with clinical parameters, is more suitable for patient triage leading to urgent endoscopy and a higher level of care. A GBS of 0 has been shown to identify patients with upper gastrointestinal bleeding who may be managed safely as outpatients. The proportion of patients requiring endoscopic therapy increases with a higher score. A cut-off score that identifies "high-risk" patients who may benefit from urgent intervention however has not been determined. Guidelines from Societies around the world recommend early endoscopy within 24 hours of presentation for acute upper gastrointestinal bleeding (AUGIB). The guidelines also state that a proportion of patients need emergency "out-of-hours" endoscopy, without defining the "high-risk" group. A recent international consensus on the management of NVUGIB recommended early endoscopy within 24 hours for Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB), and noted no additional benefit associated with urgent endoscopy (<12 hours) vs. early endoscopy (>12 hours) in unselected patients with NVUGIB. However, there are only limited data on the role of urgent endoscopy in the "selected" subgroup of patients with high-risk NVUGIB.
- Being tested
- Urgent endoscopy, Early endoscopy
- Keywords
- Glasgow-Blatchford score, Gastrointestinal bleeding
- Medical subject headings
- Peptic Ulcer Hemorrhage, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urgent endoscopyOther
Defined by oesophagogastroduodenoscopy within 6 hours of first presentation of Prince of Wales Hospital
Early endoscopyOther
Defined by oesophagogastroduodenoscopy within 24 hours of first presentation of Prince of Wales Hospital
| Study group | Role | What they receive |
|---|---|---|
| Urgent endoscopy | Active comparator | Oesophagogastroduodenoscopy done within 6hours of first GI specialists consultation Receives: Other: Urgent endoscopy |
| Early endoscopy | Placebo comparator | Oesophagogastroduodenoscopy done within 24hours of first GI specialists consultation Receives: Other: Early endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death from all causes 30 days from randomization
Measured: 30 days
Secondary outcomes (9)
Need for endoscopic therapy at index endoscopy
To measure if endoscopic therapy is needed at the index endoscopy
Measured: At the time of index endoscopy
Need for transfusion
To measure if transfusion of blood products is needed within 30days of randomization
Measured: Within 30days of randomization
Recurrent bleeding as defined
To measure if any clinical or endoscopic recurrent bleeding is identified.
Measured: Within 30days of randomization
Duration of hospital stay of index bleeding
To measure the number of days of hospital stay upon randomization, only counted the hospitalization days of index bleeding.
Measured: Within 30 days of randomization
ICU stay
To measure if ICU admission is required at the index bleeding.
Measured: Within 30days of randomization
Need for further endoscopic treatment
To measure if further endoscopic treatment if required at recurrent bleeding
Measured: Within 30days of randomization
Emergency surgery or interventional radiology to achieve hemostasis
To measure if emergency surgery or interventional radiology is needed at index bleeding or recurrent bleeding to achieve hemostasis
Measured: Within 30days of randomization
Rates of recurrent bleeding
To measure recurrent bleeding in both study arms
Measured: Within 30 days of randomization
Rate of adverse events
To measure the adverse events in either group, e.g. myocardial event, cerebrovascular event and acute renal failure.
Measured: Within 30 days of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study start28 Jul 2012
- Primary completion11 Nov 2018
- Study completion11 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bleeding Peptic UlcerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized in a 1:1 ratio. The patient is randomized to receive; 1. Urgent endoscopy (defined by endoscopy within 6 hours from first consultation by GI specialists at PWH) or 2. Early endoscopy (defined by endoscopy next morning and within 24 hours from first consultation by GI specialists at PWH)
- Masking
- None (open label)
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Yun-wong Lau, Chinese University of Hong Kong
- Investigators
- James Y LAU, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675856
- Sponsor's protocol ID
- AUGIB
- Status last verified
- Jan 2019
- First submitted
- 27 Aug 2012
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lau JYW, Yu Y, Tang RSY, Chan HCH, Yip HC, Chan SM, Luk SWY, Wong SH, Lau LHS, Lui RN, Chan TT, Mak JWY, Chan FKL, Sung JJY. Timing of Endoscopy for Acute Upper Gastrointestinal Bleeding. N Engl J Med. 2020 Apr 2;382(14):1299-1308. doi: 10.1056/NEJMoa1912484.
PubMed 32242355
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urgent vs. Early Endoscopy in High Risk Patients With UGIB
- ClinicalTrials.gov ID
- NCT01675856
- Acronym / sponsor ID
- AUGIB
- Keywords
- Glasgow-Blatchford score, Gastrointestinal bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 28 Jul 2012 (actual)
- Primary completion
- 11 Nov 2018 (actual)
- Study completion
- 11 Nov 2018 (actual)
- First posted
- 30 Aug 2012 (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.
Acute upper gastrointestinal bleeding (UGIB) is one of the commonest medical emergencies. The condition accounts for 150 per 100,000 populations. A National United Kingdom reported a crude overall mortality rate of 10%. While bleeding stops spontaneously in majority of patients at their presentation, there remains a subgroup of patients who continue to bleed or develop recurrent bleeding. In these patients, the mortality increases manifolds. If these high-risk patients can be identified, early interventions may improve their outcomes.
Several prognostic indices are in use for the purpose of patient stratification. They include the Rockall, Glasgow-Blatchford (GBS) and the Baylor scores. The Rockall score is a composite score which incorporates clinical parameters as well as findings during endoscopy which was derived to predict mortality. The GBS is a pre-endoscopy or a clinical score for the prediction for the need of further intervention loosely defined as the need for transfusion, endoscopy or surgery. It has been shown to be accurate in identifying low risk patients for early discharge.
Detailed description
The GBS, being a pre-endoscopy score with clinical parameters, is more suitable for patient triage leading to urgent endoscopy and a higher level of care. A GBS of 0 has been shown to identify patients with upper gastrointestinal bleeding who may be managed safely as outpatients. The proportion of patients requiring endoscopic therapy increases with a higher score. A cut-off score that identifies "high-risk" patients who may benefit from urgent intervention however has not been determined. Guidelines from Societies around the world recommend early endoscopy within 24 hours of presentation for acute upper gastrointestinal bleeding (AUGIB). The guidelines also state that a proportion of patients need emergency "out-of-hours" endoscopy, without defining the "high-risk" group. A recent international consensus on the management of NVUGIB recommended early endoscopy within 24 hours for Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB), and noted no additional benefit associated with urgent endoscopy (<12 hours) vs. early endoscopy (>12 hours) in unselected patients with NVUGIB. However, there are only limited data on the role of urgent endoscopy in the "selected" subgroup of patients with high-risk NVUGIB.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomized in a 1:1 ratio. The patient is randomized to receive; 1. Urgent endoscopy (defined by endoscopy within 6 hours from first consultation by GI specialists at PWH) or 2. Early endoscopy (defined by endoscopy next morning and within 24 hours from first consultation by GI specialists at PWH)
| Arm | Type | Receives |
|---|---|---|
| Urgent endoscopy | Active comparator | Other: Urgent endoscopyOesophagogastroduodenoscopy done within 6hours of first GI specialists consultation |
| Early endoscopy | Placebo comparator | Other: Early endoscopyOesophagogastroduodenoscopy done within 24hours of first GI specialists consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Overt signs of upper gastrointestinal bleeding (i.e., melena or hematemesis with or without hypotension)
- GBS of ≥12
- In-patients admitted for reasons other than AUGIB who develop bleeding are also considered for trial enrollment.
- Patients in Hypotensive shock (SBP ≤90 mmHg or pulse ≥110 bpm) are initially resuscitated and then considered for trial entry if their condition can be stabilized.
Key exclusion criteria (5 listed)
- continued shock despite initial volume resuscitation (refractory shock) undergo urgent endoscopy
- < 18 years of age
- Unable to provide written informed consent
- Pregnant or lactating women
- Moribund patients from terminal illnesses. (active treatment not considered)
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 |
|---|---|---|
| Urgent endoscopyDefined by oesophagogastroduodenoscopy within 6 hours of first presentation of Prince of Wales Hospital | Other | Urgent endoscopy |
| Early endoscopyDefined by oesophagogastroduodenoscopy within 24 hours of first presentation of Prince of Wales Hospital | Other | Early endoscopy |
Primary outcome
Mortality
Time frame: 30 days
Death from all causes 30 days from randomization
9 secondary outcomes
Need for endoscopic therapy at index endoscopy
Time frame: At the time of index endoscopy
Need for transfusion
Time frame: Within 30days of randomization
Recurrent bleeding as defined
Time frame: Within 30days of randomization
Duration of hospital stay of index bleeding
Time frame: Within 30 days of randomization
ICU stay
Time frame: Within 30days of randomization
Need for further endoscopic treatment
Time frame: Within 30days of randomization
Emergency surgery or interventional radiology to achieve hemostasis
Time frame: Within 30days of randomization
Rates of recurrent bleeding
Time frame: Within 30 days of randomization
Rate of adverse events
Time frame: Within 30 days of randomization
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 1 Feb 2019.
- Derived from this study: PubMed 32242355Lau JYW, Yu Y, Tang RSY, Chan HCH, Yip HC, Chan SM, Luk SWY, Wong SH, Lau LHS, Lui RN, Chan TT, Mak JWY, Chan FKL, Sung JJY. Timing of Endoscopy for Acute Upper Gastrointestinal Bleeding. N Engl J Med. 2020 Apr 2;382(14):1299-1308. doi: 10.1056/NEJMoa1912484.
- 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.
James Y LAU, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urgent endoscopy and Early endoscopy in people with Bleeding Peptic Ulcer and Active Bleeding, run by Chinese University of Hong Kong at 1 site in China.
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 5 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 1 Feb 2019. 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 China. 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. Some participants in this study may receive a placebo. 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 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01675856, which also lists 1 linked publication.
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 1 Feb 2019.