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

Gastrointestinal Bleeding Clinical Trial

Official title:

Urgent vs. Early Endoscopy in High Risk Patients With UGIB

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675856
• Other study ID #: AUGIB
• Status: Completed
• Phase: N/A
• Start date: July 28, 2012
• Est. completion date: November 11, 2018

Study information

• Verified date: January 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The GBS, being a pre-endoscopy score with clinical parameters, is more suitable for patient triage leading to urgent endoscopy and a higher level of care. A GBS of 0 has been shown to identify patients with upper gastrointestinal bleeding who may be managed safely as outpatients. The proportion of patients requiring endoscopic therapy increases with a higher score. A cut-off score that identifies "high-risk" patients who may benefit from urgent intervention however has not been determined. Guidelines from Societies around the world recommend early endoscopy within 24 hours of presentation for acute upper gastrointestinal bleeding (AUGIB). The guidelines also state that a proportion of patients need emergency "out-of-hours" endoscopy, without defining the "high-risk" group. A recent international consensus on the management of NVUGIB recommended early endoscopy within 24 hours for Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB), and noted no additional benefit associated with urgent endoscopy (<12 hours) vs. early endoscopy (>12 hours) in unselected patients with NVUGIB. However, there are only limited data on the role of urgent endoscopy in the "selected" subgroup of patients with high-risk NVUGIB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: November 11, 2018
• Est. primary completion date: November 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Overt signs of upper gastrointestinal bleeding (i.e., melena or hematemesis with or without hypotension)

2. GBS of =12

3. In-patients admitted for reasons other than AUGIB who develop bleeding are also considered for trial enrollment.

4. 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.

Exclusion Criteria:

1. continued shock despite initial volume resuscitation (refractory shock) undergo urgent endoscopy

2. < 18 years of age

3. Unable to provide written informed consent

4. Pregnant or lactating women

5. Moribund patients from terminal illnesses. (active treatment not considered)

Related Conditions & MeSH terms

• Active Bleeding
• Bleeding Peptic Ulcer
• Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage

Intervention

Other:
• Urgent endoscopy
Defined by oesophagogastroduodenoscopy within 6 hours of first presentation of Prince of Wales Hospital
• Early endoscopy
Defined by oesophagogastroduodenoscopy within 24 hours of first presentation of Prince of Wales Hospital

Locations

Country	Name	City	State
China	Endoscopy Centre, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death from all causes 30 days from randomization	30 days
Secondary	Need for endoscopic therapy at index endoscopy	To measure if endoscopic therapy is needed at the index endoscopy	At the time of index endoscopy
Secondary	Need for transfusion	To measure if transfusion of blood products is needed within 30days of randomization	Within 30days of randomization
Secondary	Recurrent bleeding as defined	To measure if any clinical or endoscopic recurrent bleeding is identified.	Within 30days of randomization
Secondary	Duration of hospital stay of index bleeding	To measure the number of days of hospital stay upon randomization, only counted the hospitalization days of index bleeding.	Within 30 days of randomization
Secondary	ICU stay	To measure if ICU admission is required at the index bleeding.	Within 30days of randomization
Secondary	Need for further endoscopic treatment	To measure if further endoscopic treatment if required at recurrent bleeding	Within 30days of randomization
Secondary	Emergency surgery or interventional radiology to achieve hemostasis	To measure if emergency surgery or interventional radiology is needed at index bleeding or recurrent bleeding to achieve hemostasis	Within 30days of randomization
Secondary	Rates of recurrent bleeding	To measure recurrent bleeding in both study arms	Within 30 days of randomization
Secondary	Rate of adverse events	To measure the adverse events in either group, e.g. myocardial event, cerebrovascular event and acute renal failure.	Within 30 days of randomization