Upper Gastrointestinal BleedingNCT03337256
Direct Discharge of Patients With Upper Gastrointestinal Bleeding From the Emergency Department After Endoscopy
A study testing GI bleeding score in people with Upper Gastrointestinal Bleeding, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
Acute upper gastrointestinal bleeding (UGIB) is a common cause for attendance to the Emergency Department with a wide range of clinical severity, ranging from insignificant to life-threatening. 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?
- GI bleeding score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 762 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Sep 2015to 28 Feb 2026
- 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
- All patients attending either the Prince of Wales Hospital or Alice Ho Miu Ling Nethersole hospital with symptoms of upper gastrointestinal bleeding will be initially resuscitated and stabilized in the Accident \& Emergency Department (AED) as per local practice
Who cannot join
- Incapable of providing informed consent
- Age <18 years old
- Pregnancy
- Medically unfit to receive an upper endoscopy procedure (require O2 supplement >3L/min, persistent haemodynamic instability despite initial resuscitation, mental confusion)
- Require admission to intensive care unit
- Require emergency endoscopy for uncontrolled gastrointestinal bleeding
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Alice Ho Miu Ling Nethersole Hospital
Hong Kong
Prince of Wales Hospital
Hong Kong
About this study
Official title: Direct Discharge of Patients With Upper Gastrointestinal Bleeding From the Emergency Department After Endoscopy: A Feasibility Study (GIB Score 002 Study)
Acute upper gastrointestinal bleeding (UGIB) is a common cause for attendance to the Emergency Department with a wide range of clinical severity, ranging from insignificant to life-threatening. While there is robust data to support the benefit of upper endoscopy within 24 hours of admission, the implementation of early upper endoscopy while patients are still in the emergency room has not been widely accepted due to lack of added benefit in terms of patient outcome such as mortality and re-bleeding rate. However, the use of upper endoscopy in the emergency room with the purpose of facilitating early discharge of low risk patients with upper gastrointestinal bleeding has not been studied.
Read the detailed description
The Glasgow Blatchford Score (GBS) was developed in 2000 to identify very low risk patients who would not need any intervention and were of low risk of rebleeding and death. The GBS used objective clinical parameters that could be easily obtained in the emergency department and did not use any endoscopy findings as parameters. Unlike the Rockall score which was designed to identify high risk patients, the GBS was used to identify low risk patients who could be safely discharged from the emergency department without endoscopy and studies have shown it to be superior in this regard. The main limitation of GBS is its low specificity with only 4-8% of all patients presenting with upper gastrointestinal bleeding stratified as low risk. Furthermore, the GBS was derived from a Scottish gastrointestinal bleeding registry and may not be applicable to the local population.
Suitable patients attending the Accident \& Emergency Department for symptoms of upper gastrointestinal bleeding will be identified and recruited by the Accident \& Emergency physicians. Patients presenting to Endoscopy Centre after admission will also be recruited to collect clinical data.
Univariate analysis was carried out on the development set using Pearson's chi-square method to examine the association among the factors on the outcome. Variables significantly associated with 30 day re-attendance rate in univariate analyses (P<=0.1) will be entered in multivariate logistic regression models. Risk factors which retained significance in multivariate analyses will be selected for incorporation into the risk score. A weighting will be assigned to each independent variable in the risk score, applying the corresponding adjusted odds ratio (AOR). The risk score for each subject is the sum of all the risk factors. To evaluate the predictive ability of the scoring system, a receiver operating characteristic (ROC) curve was constructed and the area under the curve (AUC) was delineated. A concordance (c)-statistics was used to reflect the discriminative ability of the prediction tool.
Cost-effective economical model will be used in cost effective analysis of the use of early discharge strategy.
- Conditions
- Upper Gastrointestinal Bleeding
- Being tested
- GI bleeding score
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI bleeding scoreDiagnostic test
Risk factor Score component value Age (years) 15-29 -2 30-44 -1.5 45-59 0 60-74 1.5
- 75 2.5 Haemoglobin(g/L)
- 10.0 0 <9.9 2 Systolic blood pressure (mmHg)
- 110 0 90-109 1.5 <90 2.5 Pulse (beats per min) <100 0
- 100 1.5 Creatinine (mmol/L) <200 0
- 200 3.5 Number of blood transfusion 0 0 1 1.5
- 2 2 Presenting symptom Melaena -1.5 Drug treatment Acid blcoking drug 1.5 anticoagulant 3 Endoscopy findings Clean-based ulcer -2 SRH or blood in stomach 4 Varices 5
| Study group | Role | What they receive |
|---|---|---|
| GI bleeding score | Experimental | Early endoscopy in emergency department + other clinical parameters Receives: Diagnostic Test: GI bleeding score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-attendance rate to emergency department
re-attendance rate to emergency department for upper gastrointestinal bleeding
Measured: 30-day
Secondary outcomes (4)
Mortality rate
all-cause mortality rate
Measured: 30-day
Re-attendance rate to emergency department
all cause re-attendance to emergency department for upper gastrointestinal bleeding
Measured: 30-day
Length of hospital stay
Number of days of hospitalization
Measured: 30-day
Need for further medical intervention
Need for further medical intervention both before and after the first upper endoscopy
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Sep 2015
- Primary completion31 Aug 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
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 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
- Not applicable
- Intervention model
- Single group
- Model description
- Early endoscopy in emergency department + other clinical parameters
- Masking
- None (open label)
- Enrolment
- 762 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aric Josun Hui, Chinese University of Hong Kong
- Investigators
- Aric Josun Hui, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337256
- Sponsor's protocol ID
- GIB Score 002
- Status last verified
- Apr 2020
- First submitted
- 6 Nov 2017
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Discharge of Patients With Upper Gastrointestinal Bleeding From the Emergency Department After Endoscopy: A Feasibility Study (GIB Score 002 Study)
- ClinicalTrials.gov ID
- NCT03337256
- Acronym / sponsor ID
- GIB Score 002
- Conditions
- Upper Gastrointestinal Bleeding
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 762 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 8 Nov 2017 (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.
Acute upper gastrointestinal bleeding (UGIB) is a common cause for attendance to the Emergency Department with a wide range of clinical severity, ranging from insignificant to life-threatening. While there is robust data to support the benefit of upper endoscopy within 24 hours of admission, the implementation of early upper endoscopy while patients are still in the emergency room has not been widely accepted due to lack of added benefit in terms of patient outcome such as mortality and re-bleeding rate. However, the use of upper endoscopy in the emergency room with the purpose of facilitating early discharge of low risk patients with upper gastrointestinal bleeding has not been studied.
Detailed description
The Glasgow Blatchford Score (GBS) was developed in 2000 to identify very low risk patients who would not need any intervention and were of low risk of rebleeding and death. The GBS used objective clinical parameters that could be easily obtained in the emergency department and did not use any endoscopy findings as parameters. Unlike the Rockall score which was designed to identify high risk patients, the GBS was used to identify low risk patients who could be safely discharged from the emergency department without endoscopy and studies have shown it to be superior in this regard. The main limitation of GBS is its low specificity with only 4-8% of all patients presenting with upper gastrointestinal bleeding stratified as low risk. Furthermore, the GBS was derived from a Scottish gastrointestinal bleeding registry and may not be applicable to the local population.
Suitable patients attending the Accident \& Emergency Department for symptoms of upper gastrointestinal bleeding will be identified and recruited by the Accident \& Emergency physicians. Patients presenting to Endoscopy Centre after admission will also be recruited to collect clinical data.
Univariate analysis was carried out on the development set using Pearson's chi-square method to examine the association among the factors on the outcome. Variables significantly associated with 30 day re-attendance rate in univariate analyses (P<=0.1) will be entered in multivariate logistic regression models. Risk factors which retained significance in multivariate analyses will be selected for incorporation into the risk score. A weighting will be assigned to each independent variable in the risk score, applying the corresponding adjusted odds ratio (AOR). The risk score for each subject is the sum of all the risk factors. To evaluate the predictive ability of the scoring system, a receiver operating characteristic (ROC) curve was constructed and the area under the curve (AUC) was delineated. A concordance (c)-statistics was used to reflect the discriminative ability of the prediction tool.
Cost-effective economical model will be used in cost effective analysis of the use of early discharge strategy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Early endoscopy in emergency department + other clinical parameters
| Arm | Type | Receives |
|---|---|---|
| GI bleeding score | Experimental | Diagnostic Test: GI bleeding scoreEarly endoscopy in emergency department + other clinical parameters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients attending either the Prince of Wales Hospital or Alice Ho Miu Ling Nethersole hospital with symptoms of upper gastrointestinal bleeding will be initially resuscitated and stabilized in the Accident \& Emergency Department (AED) as per local practice
Key exclusion criteria (6 listed)
- Incapable of providing informed consent
- Age <18 years old
- Pregnancy
- Medically unfit to receive an upper endoscopy procedure (require O2 supplement >3L/min, persistent haemodynamic instability despite initial resuscitation, mental confusion)
- Require admission to intensive care unit
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 |
|---|---|---|
| GI bleeding scoreRisk factor Score component value Age (years) 15-29 -2 30-44 -1.5 45-59 0 60-74 1.5 * 75 2.5 Haemoglobin(g/L) * 10.0 0 <9.9 2 Systolic blood pressure (mmHg) * 110 0 90-109 1.5 <90 2.5 Pulse (beats per min) <100 0 * 100 1.5 Creatinine (mmol/L) <200 0 * 200 3.5 Number of blood transfusion 0 0 1 1.5 * 2 2 Presenting symptom Melaena -1.5 Drug treatment Acid blcoking drug 1.5 anticoagulant 3 Endoscopy findings Clean-based ulcer -2 SRH or blood in stomach 4 Varices 5 | Diagnostic test | GI bleeding score |
Primary outcome
Re-attendance rate to emergency department
Time frame: 30-day
re-attendance rate to emergency department for upper gastrointestinal bleeding
4 secondary outcomes
Mortality rate
Time frame: 30-day
Re-attendance rate to emergency department
Time frame: 30-day
Length of hospital stay
Time frame: 30-day
Need for further medical intervention
Time frame: 30-day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Aric Josun Hui, MD principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GI bleeding score in people with Upper Gastrointestinal Bleeding, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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 1 inclusion and 6 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: paused, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. 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?
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?
Re-attendance rate to emergency department (time frame: 30-day). 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 9 Apr 2020; AzTrials last refreshed its copy on 7 Nov 2026.