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

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Suspended
CT.gov ID
NCT03337256
Collaborator
(none)
762
2
1
125.9
381
3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: GI bleeding score
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
762 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Early endoscopy in emergency department + other clinical parametersEarly endoscopy in emergency department + other clinical parameters
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Direct Discharge of Patients With Upper Gastrointestinal Bleeding From the Emergency Department After Endoscopy: A Feasibility Study (GIB Score 002 Study)
Actual Study Start Date :
Sep 1, 2015
Anticipated Primary Completion Date :
Aug 31, 2025
Anticipated Study Completion Date :
Feb 28, 2026

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures

  1. Re-attendance rate to emergency department [30-day]

    re-attendance rate to emergency department for upper gastrointestinal bleeding

Secondary Outcome Measures

  1. Mortality rate [30-day]

    all-cause mortality rate

  2. Re-attendance rate to emergency department [30-day]

    all cause re-attendance to emergency department for upper gastrointestinal bleeding

  3. Length of hospital stay [30-day]

    Number of days of hospitalization

  4. Need for further medical intervention [30-day]

    Need for further medical intervention both before and after the first upper endoscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

  1. Require admission to intensive care unit

  2. Require emergency endoscopy for uncontrolled gastrointestinal bleeding

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alice Ho Miu Ling Nethersole Hospital Hong Kong Hong Kong
2 Prince of Wales Hospital Hong Kong Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aric Josun Hui, Conultant-in-charge, Combined Endoscopy Unit, Alice Ho Miu Ling Nethersole Hospital, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT03337256
Other Study ID Numbers:
  • GIB Score 002
First Posted:
Nov 8, 2017
Last Update Posted:
Apr 9, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 9, 2020