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Completed

NCT Number: NCT01675856

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Urgent endoscopy

Other

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

Early endoscopy

Other

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

Primary outcomes

  1. Mortality

    Time frame: 30 days

    Death from all causes 30 days from randomization

Secondary outcomes

  1. Need for endoscopic therapy at index endoscopy

    Time frame: At the time of index endoscopy

    To measure if endoscopic therapy is needed at the index endoscopy

  2. Need for transfusion

    Time frame: Within 30days of randomization

    To measure if transfusion of blood products is needed within 30days of randomization

  3. Recurrent bleeding as defined

    Time frame: Within 30days of randomization

    To measure if any clinical or endoscopic recurrent bleeding is identified.

  4. Duration of hospital stay of index bleeding

    Time frame: Within 30 days of randomization

    To measure the number of days of hospital stay upon randomization, only counted the hospitalization days of index bleeding.

  5. ICU stay

    Time frame: Within 30days of randomization

    To measure if ICU admission is required at the index bleeding.

  6. Need for further endoscopic treatment

    Time frame: Within 30days of randomization

    To measure if further endoscopic treatment if required at recurrent bleeding

  7. Emergency surgery or interventional radiology to achieve hemostasis

    Time frame: Within 30days of randomization

    To measure if emergency surgery or interventional radiology is needed at index bleeding or recurrent bleeding to achieve hemostasis

  8. Rates of recurrent bleeding

    Time frame: Within 30 days of randomization

    To measure recurrent bleeding in both study arms

  9. Rate of adverse events

    Time frame: Within 30 days of randomization

    To measure the adverse events in either group, e.g. myocardial event, cerebrovascular event and acute renal failure.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Urgent vs. Early Endoscopy in High Risk Patients With UGIB

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Aug 30, 2012
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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