Urgent vs. Early Endoscopy in High Risk Patients With Upper Gastrointestinal Bleeding (UGIB)

NCT01675856 | Completed

• 1 other identifier: AUGIB
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 1

Brief Summary

Acute upper gastrointestinal bleeding (UGIB) is one of the commonest medical emergencies. The condition accounts for 150 per 100,000 populations. A National United Kingdom reported a crude overall mortality rate of 10%. While bleeding stops spontaneously in majority of patients at their presentation, there remains a subgroup of patients who continue to bleed or develop recurrent bleeding. In these patients, the mortality increases manifolds. If these high-risk patients can be identified, early interventions may improve their outcomes. Several prognostic indices are in use for the purpose of patient stratification. They include the Rockall, Glasgow-Blatchford (GBS) and the Baylor scores. The Rockall score is a composite score which incorporates clinical parameters as well as findings during endoscopy which was derived to predict mortality. The GBS is a pre-endoscopy or a clinical score for the prediction for the need of further intervention loosely defined as the need for transfusion, endoscopy or surgery. It has been shown to be accurate in identifying low risk patients for early discharge.

Conditions

Bleeding Peptic Ulcer; Active Bleeding; Gastrointestinal Bleeding

Keywords

Glasgow-Blatchford score; Gastrointestinal bleeding

Outcome Measures

Primary Outcomes (1)

• Mortality

  Death from all causes 30 days from randomization

  30 days

Secondary Outcomes (9)

• Need for endoscopic therapy at index endoscopy

  At the time of index endoscopy

• Need for transfusion

  Within 30days of randomization

• Recurrent bleeding as defined

  Within 30days of randomization

• Duration of hospital stay of index bleeding

  Within 30 days of randomization

• ICU stay

  Within 30days of randomization

Study Arms (2)

Urgent endoscopy

ACTIVE COMPARATOR

Oesophagogastroduodenoscopy done within 6hours of first GI specialists consultation

Other: Urgent endoscopy

Early endoscopy

PLACEBO COMPARATOR

Oesophagogastroduodenoscopy done within 24hours of first GI specialists consultation

Other: Early endoscopy

Interventions

Urgent endoscopy OTHER

Defined by oesophagogastroduodenoscopy within 6 hours of first presentation of Prince of Wales Hospital

Urgent endoscopy

Early endoscopy OTHER

Defined by oesophagogastroduodenoscopy within 24 hours of first presentation of Prince of Wales Hospital

Early endoscopy

Eligibility Criteria

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

You may qualify if:

• Overt signs of upper gastrointestinal bleeding (i.e., melena or hematemesis with or without hypotension)
• GBS of ≥12
• In-patients admitted for reasons other than AUGIB who develop bleeding are also considered for trial enrollment.
• Patients in Hypotensive shock (SBP ≤90 mmHg or pulse ≥110 bpm) are initially resuscitated and then considered for trial entry if their condition can be stabilized.

You may not qualify if:

• continued shock despite initial volume resuscitation (refractory shock) undergo urgent endoscopy
• \< 18 years of age
• Unable to provide written informed consent
• Pregnant or lactating women
• Moribund patients from terminal illnesses. (active treatment not considered)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, China

Location

Related Publications (1)

• Lau JYW, Yu Y, Tang RSY, Chan HCH, Yip HC, Chan SM, Luk SWY, Wong SH, Lau LHS, Lui RN, Chan TT, Mak JWY, Chan FKL, Sung JJY. Timing of Endoscopy for Acute Upper Gastrointestinal Bleeding. N Engl J Med. 2020 Apr 2;382(14):1299-1308. doi: 10.1056/NEJMoa1912484.

  PMID: 32242355 DERIVED

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage; Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• James Y LAU, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients are randomized in a 1:1 ratio. The patient is randomized to receive; 1. Urgent endoscopy (defined by endoscopy within 6 hours from first consultation by GI specialists at PWH) or 2. Early endoscopy (defined by endoscopy next morning and within 24 hours from first consultation by GI specialists at PWH)

Study Record Dates

• First Submitted: August 27, 2012
• First Posted: August 30, 2012
• Study Start: July 28, 2012
• Primary Completion: November 11, 2018
• Study Completion: November 11, 2018
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)