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

NCT03337256 | Suspended DMC

• 1 other identifier: GIB Score 002
• Study Type: interventional
• Target: 762
• Locations: 1 country
• Sites: 2

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.

Conditions

Upper Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• Re-attendance rate to emergency department

  re-attendance rate to emergency department for upper gastrointestinal bleeding

  30-day

Secondary Outcomes (4)

• Mortality rate

  30-day

• Re-attendance rate to emergency department

  30-day

• Length of hospital stay

  30-day

• Need for further medical intervention

  30-day

Study Arms (1)

GI bleeding score

EXPERIMENTAL

Early endoscopy in emergency department + other clinical parameters

Diagnostic Test: GI bleeding score

Interventions

GI bleeding score DIAGNOSTIC_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

GI bleeding score

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Alice Ho Miu Ling Nethersole Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aric Josun Hui, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Conultant-in-charge, Combined Endoscopy Unit, Alice Ho Miu Ling Nethersole Hospital

Model Details: Early endoscopy in emergency department + other clinical parameters

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 8, 2017
• Study Start: September 1, 2015
• Primary Completion: August 31, 2025
• Study Completion: February 28, 2026
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

HK (2)