Direct Discharge of Patients With Upper Gastrointestinal Bleeding From the Emergency Department After Endoscopy
Primary Purpose
Upper Gastrointestinal Bleeding
Status
Suspended
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
GI bleeding score
Sponsored by
About this trial
This is an interventional diagnostic trial for Upper Gastrointestinal Bleeding
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Alice Ho Miu Ling Nethersole Hospital
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GI bleeding score
Arm Description
Early endoscopy in emergency department + other clinical parameters
Outcomes
Primary Outcome Measures
Re-attendance rate to emergency department
re-attendance rate to emergency department for upper gastrointestinal bleeding
Secondary Outcome Measures
Mortality rate
all-cause mortality rate
Re-attendance rate to emergency department
all cause re-attendance to emergency department for upper gastrointestinal bleeding
Length of hospital stay
Number of days of hospitalization
Need for further medical intervention
Need for further medical intervention both before and after the first upper endoscopy
Full Information
NCT ID
NCT03337256
First Posted
November 6, 2017
Last Updated
April 7, 2020
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03337256
Brief Title
Direct Discharge of Patients With Upper Gastrointestinal Bleeding From the Emergency Department After Endoscopy
Official Title
Direct Discharge of Patients With Upper Gastrointestinal Bleeding From the Emergency Department After Endoscopy: A Feasibility Study (GIB Score 002 Study)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Suspended
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Bleeding
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Early endoscopy in emergency department + other clinical parameters
Masking
None (Open Label)
Allocation
N/A
Enrollment
762 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GI bleeding score
Arm Type
Experimental
Arm Description
Early endoscopy in emergency department + other clinical parameters
Intervention Type
Diagnostic Test
Intervention Name(s)
GI bleeding score
Intervention Description
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
Primary Outcome Measure Information:
Title
Re-attendance rate to emergency department
Description
re-attendance rate to emergency department for upper gastrointestinal bleeding
Time Frame
30-day
Secondary Outcome Measure Information:
Title
Mortality rate
Description
all-cause mortality rate
Time Frame
30-day
Title
Re-attendance rate to emergency department
Description
all cause re-attendance to emergency department for upper gastrointestinal bleeding
Time Frame
30-day
Title
Length of hospital stay
Description
Number of days of hospitalization
Time Frame
30-day
Title
Need for further medical intervention
Description
Need for further medical intervention both before and after the first upper endoscopy
Time Frame
30-day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aric Josun Hui, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Direct Discharge of Patients With Upper Gastrointestinal Bleeding From the Emergency Department After Endoscopy
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