Direct Discharge of Patients With Upper Gastrointestinal Bleeding From the Emergency Department After Endoscopy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03337256|
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : June 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Upper Gastrointestinal Bleeding||Diagnostic Test: GI bleeding score||Not Applicable|
The Glasgow Blatchford Score (GBS) was developed in 2000 to identify very low risk patients who would not need any intervention and were of low risk of rebleeding and death. The GBS used objective clinical parameters that could be easily obtained in the emergency department and did not use any endoscopy findings as parameters. Unlike the Rockall score which was designed to identify high risk patients, the GBS was used to identify low risk patients who could be safely discharged from the emergency department without endoscopy and studies have shown it to be superior in this regard. The main limitation of GBS is its low specificity with only 4-8% of all patients presenting with upper gastrointestinal bleeding stratified as low risk. Furthermore, the GBS was derived from a Scottish gastrointestinal bleeding registry and may not be applicable to the local population.
Suitable patients attending the Accident & Emergency Department for symptoms of upper gastrointestinal bleeding will be identified and recruited by the Accident & Emergency physicians. Patients presenting to Endoscopy Centre after admission will also be recruited to collect clinical data.
Univariate analysis was carried out on the development set using Pearson's chi-square method to examine the association among the factors on the outcome. Variables significantly associated with 30 day re-attendance rate in univariate analyses (P<=0.1) will be entered in multivariate logistic regression models. Risk factors which retained significance in multivariate analyses will be selected for incorporation into the risk score. A weighting will be assigned to each independent variable in the risk score, applying the corresponding adjusted odds ratio (AOR). The risk score for each subject is the sum of all the risk factors. To evaluate the predictive ability of the scoring system, a receiver operating characteristic (ROC) curve was constructed and the area under the curve (AUC) was delineated. A concordance (c)-statistics was used to reflect the discriminative ability of the prediction tool.
Cost-effective economical model will be used in cost effective analysis of the use of early discharge strategy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||762 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Early endoscopy in emergency department + other clinical parameters|
|Masking:||None (Open Label)|
|Official Title:||Direct Discharge of Patients With Upper Gastrointestinal Bleeding From the Emergency Department After Endoscopy: A Feasibility Study (GIB Score 002 Study)|
|Actual Study Start Date :||September 1, 2015|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||February 28, 2020|
Experimental: GI bleeding score
Early endoscopy in emergency department + other clinical parameters
Diagnostic Test: GI bleeding score
Risk factor Score component value Age (years) 15-29 -2 30-44 -1.5 45-59 0 60-74 1.5
- Re-attendance rate to emergency department [ Time Frame: 30-day ]re-attendance rate to emergency department for upper gastrointestinal bleeding
- Mortality rate [ Time Frame: 30-day ]all-cause mortality rate
- Re-attendance rate to emergency department [ Time Frame: 30-day ]all cause re-attendance to emergency department for upper gastrointestinal bleeding
- Length of hospital stay [ Time Frame: 30-day ]Number of days of hospitalization
- Need for further medical intervention [ Time Frame: 30-day ]Need for further medical intervention both before and after the first upper endoscopy
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): NCT03337256
|Contact: Thoams Y.T. Lam, MSc||+852 2637 email@example.com|
|Alice Ho Miu Ling Nethersole Hospital||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Thomas Y.T. Lam, MSc +852 2637 0355 firstname.lastname@example.org|
|Prince of Wales Hospital||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Thomas Y Lam, MSc +852 26370355 email@example.com|
|Principal Investigator:||Aric Josun Hui, MD||Chinese University of Hong Kong|