NCT01675856

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

Completed NA Last updated 1 February 2019

What this trial tests

NA trial testing Urgent endoscopy in Bleeding Peptic Ulcer in 516 participants. Completed in 11 November 2018.

Timeline

28 July 2012

Primary endpoint
11 November 2018

11 November 2018

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	516
Start date	28 July 2012
Primary completion	11 November 2018
Estimated completion	11 November 2018
Sites	1 location across China

Drugs / interventions tested

• Urgent endoscopy
• Early endoscopy

Conditions studied

• Bleeding Peptic Ulcer — all drugs for Bleeding Peptic Ulcer →
• Active Bleeding — all drugs for Active Bleeding →
• Gastrointestinal Bleeding — all drugs for Gastrointestinal Bleeding →

Sponsor

Chinese University of Hong Kong

Who can join

18 and older, any sex, with Bleeding Peptic Ulcer or Active Bleeding. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Timing of Endoscopy for Acute Upper Gastrointestinal Bleeding.
   Lau JYW, Yu Y, Tang RSY, Chan HCH, et al · · 2020 · cited 208× · PMID 32242355 · DOI 10.1056/nejmoa1912484