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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01675856
First received: August 27, 2012
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Bleeding Peptic Ulcer
Active Bleeding
Gastrointestinal Bleeding
Other: Urgent endoscopy
Other: Early endoscopy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Urgent vs. Early Endoscopy in High Risk Patients With UGIB

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Death from all causes 30 days from randomization


Secondary Outcome Measures:
  • Need for endoscopic therapy at index endoscopy [ Time Frame: At the time of index endoscopy ] [ Designated as safety issue: No ]
    To measure if endoscopic therapy is needed at the index endoscopy

  • Need for transfusion [ Time Frame: Within 30days of randomization ] [ Designated as safety issue: No ]
    To measure if transfusion of blood products is needed within 30days of randomization

  • Recurrent bleeding as defined [ Time Frame: Within 30days of randomization ] [ Designated as safety issue: No ]
    To measure if any clinical or endoscopic recurrent bleeding is identified.

  • Duration of hospital stay of index bleeding [ Time Frame: Within 30 days of randomization ] [ Designated as safety issue: No ]
    To measure the number of days of hospital stay upon randomization, only counted the hospitalization days of index bleeding.

  • ICU stay [ Time Frame: Within 30days of randomization ] [ Designated as safety issue: No ]
    To measure if ICU admission is required at the index bleeding.

  • Need for further endoscopic treatment [ Time Frame: Within 30days of randomization ] [ Designated as safety issue: No ]
    To measure if further endoscopic treatment if required at recurrent bleeding

  • Emergency surgery or interventional radiology to achieve hemostasis [ Time Frame: Within 30days of randomization ] [ Designated as safety issue: No ]
    To measure if emergency surgery or interventional radiology is needed at index bleeding or recurrent bleeding to achieve hemostasis

  • Rates of recurrent bleeding [ Time Frame: Within 30 days of randomization ] [ Designated as safety issue: No ]
    To measure recurrent bleeding in both study arms

  • Rate of adverse events [ Time Frame: Within 30 days of randomization ] [ Designated as safety issue: No ]
    To measure the adverse events in either group, e.g. myocardial event, cerebrovascular event and acute renal failure.


Estimated Enrollment: 180
Study Start Date: July 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Urgent endoscopy
Oesophagogastroduodenoscopy done within 6hours of first GI specialists consultation
Other: Urgent endoscopy
Defined by oesophagogastroduodenoscopy within 6 hours of first presentation of Prince of Wales Hospital
Placebo Comparator: Early endoscopy
Oesophagogastroduodenoscopy done within 24hours of first GI specialists consultation
Other: Early endoscopy
Defined by oesophagogastroduodenoscopy within 24 hours of first presentation of Prince of Wales Hospital

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675856

Contacts
Contact: James Y LAU, MD +852 2632 1411 laujyw@surgery.cuhk.edu.hk
Contact: Kim W AU, MSc +852 2632 2640 kimau@surgery.cuhk.edu.hk

Locations
China
Endoscopy Centre, Prince of Wales Hospital Recruiting
Hong Kong, China
Contact: James Y LAU, MD    +852 2632 1411    laujyw@surgery.cuhk.edu.hk   
Contact: Kim W AU, MSc    +852 2632 2640    kimau@surgery.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: James Y LAU, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01675856     History of Changes
Other Study ID Numbers: AUGIB
Study First Received: August 27, 2012
Last Updated: July 29, 2013
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Glasgow-Blatchford score
Gastrointestinal bleeding

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Digestive System Diseases
Duodenal Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Stomach Diseases

ClinicalTrials.gov processed this record on November 27, 2014