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

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ClinicalTrials.gov Identifier: NCT03337256
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Aric Josun Hui, Chinese University of Hong Kong

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
Upper Gastrointestinal Bleeding Diagnostic Test: GI bleeding score Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 762 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Early 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 : September 1, 2015
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Re-attendance rate to emergency department [ Time Frame: 30-day ]
    re-attendance rate to emergency department for upper gastrointestinal bleeding


Secondary Outcome Measures :
  1. Mortality rate [ Time Frame: 30-day ]
    all-cause mortality rate

  2. Re-attendance rate to emergency department [ Time Frame: 30-day ]
    all cause re-attendance to emergency department for upper gastrointestinal bleeding

  3. Length of hospital stay [ Time Frame: 30-day ]
    Number of days of hospitalization

  4. Need for further medical intervention [ Time Frame: 30-day ]
    Need for further medical intervention both before and after the first upper endoscopy



Information from the National Library of Medicine

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

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337256


Contacts
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Contact: Thoams Y.T. Lam, MSc +852 2637 0355 thomaslam@cuhk.edu.hk

Locations
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Hong Kong
Alice Ho Miu Ling Nethersole Hospital Recruiting
Hong Kong, Hong Kong
Contact: Thomas Y.T. Lam, MSc    +852 2637 0355    thomaslam@cuhk.edu.hk   
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Thomas Y Lam, MSc    +852 26370355    thomaslam@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Aric Josun Hui, MD Chinese University of Hong Kong

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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     History of Changes
Other Study ID Numbers: GIB Score 002
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Emergencies
Hemorrhage
Disease Attributes
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases