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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01675856
Other study ID # AUGIB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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