Direct Discharge of Patients With Upper Gastrointestinal Bleeding From the Emergency Department After Endoscopy

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.

Study Overview

• Status: Suspended
• Conditions: Upper Gastrointestinal Bleeding
• Intervention / Treatment: Diagnostic test: GI bleeding score

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 Type: Interventional
• Enrollment (Anticipated): 762
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
  • Hong Kong, Hong Kong
    • Alice Ho Miu Ling Nethersole Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. Incapable of providing informed consent
2. Age <18 years old
3. Pregnancy
4. Medically unfit to receive an upper endoscopy procedure (require O2 supplement >3L/min, persistent haemodynamic instability despite initial resuscitation, mental confusion)
5. Require admission to intensive care unit
6. Require emergency endoscopy for uncontrolled gastrointestinal bleeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: GI bleeding score; Early endoscopy in emergency department + other clinical parameters

Diagnostic test: GI bleeding score; 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 01 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-attendance rate to emergency department	re-attendance rate to emergency department for upper gastrointestinal bleeding	30-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	all-cause mortality rate	30-day
Re-attendance rate to emergency department	all cause re-attendance to emergency department for upper gastrointestinal bleeding	30-day
Length of hospital stay	Number of days of hospitalization	30-day
Need for further medical intervention	Need for further medical intervention both before and after the first upper endoscopy	30-day

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Aric Josun Hui, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2015
• Primary Completion (ANTICIPATED): August 31, 2025
• Study Completion (ANTICIPATED): February 28, 2026

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (ACTUAL): November 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Emergencies; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: GIB Score 002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No