Urgent vs. Early Endoscopy in High Risk Patients With Upper Gastrointestinal Bleeding (UGIB)
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|ClinicalTrials.gov Identifier: NCT01675856|
Recruitment Status : Recruiting
First Posted : August 30, 2012
Last Update Posted : January 25, 2018
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 or disease||Intervention/treatment||Phase|
|Bleeding Peptic Ulcer Active Bleeding Gastrointestinal Bleeding||Other: Urgent endoscopy Other: Early endoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||516 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Patients are randomized in a 1:1 ratio. The patient is randomized to receive;
|Masking:||None (Open Label)|
|Official Title:||Urgent vs. Early Endoscopy in High Risk Patients With UGIB|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
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
- Mortality [ Time Frame: 30 days ]Death from all causes 30 days from randomization
- 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
- Need for transfusion [ Time Frame: Within 30days of randomization ]To measure if transfusion of blood products is needed within 30days of randomization
- Recurrent bleeding as defined [ Time Frame: Within 30days of randomization ]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 ]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 ]To measure if ICU admission is required at the index bleeding.
- Need for further endoscopic treatment [ Time Frame: Within 30days of randomization ]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 ]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 ]To measure recurrent bleeding in both study arms
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675856
|Contact: James Y LAU, MD||+852 2632 firstname.lastname@example.org|
|Contact: Kim W AU, MSc||+852 2632 email@example.com|
|Endoscopy Centre, Prince of Wales Hospital||Recruiting|
|Hong Kong, China|
|Contact: James Y LAU, MD +852 2632 1411 firstname.lastname@example.org|
|Contact: Kim W AU, MSc +852 2632 2640 email@example.com|
|Principal Investigator:||James Y LAU, MD||Chinese University of Hong Kong|