CTRI Number |
CTRI/2019/03/018127 [Registered on: 15/03/2019] Trial Registered Prospectively |
Last Modified On: |
29/03/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Follow Up Study |
Study Design |
Other |
Public Title of Study
|
RISK STRATIFICATION OF PATIENTS PRESENTING WITH UPPER GASTROINTESTINAL BLEEDING TO
THE EMERGENCY DEPARTMENT |
Scientific Title of Study
|
RISK STRATIFICATION OF PATIENTS PRESENTING WITH UPPER GASTROINTESTINAL BLEEDING TO
THE EMERGENCY DEPARTMENT USING
AIMS65 SCORE AND RED CELL DISTRIBUTION WIDTH |
Trial Acronym |
RUGBE TRIAL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
U1111-1224-9426 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Vijay Chanchal A B |
Designation |
PG RESIDENT |
Affiliation |
JUBILEE MISSION MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Address |
DEPARTMENT OF EMERGENCY MEDICINE, JUBILEE MISSION MEDICAL COLLEGE AND RESEARCH INSTITUTE, THRISSUR
Thrissur KERALA 680005 India |
Phone |
9496866775 |
Fax |
|
Email |
v4vijay007@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
P C RAJEEV |
Designation |
ASSOCIATE PROFESSOR |
Affiliation |
JUBILEE MISSION MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Address |
DEPARTMENT OF EMERGENCY MEDICINE, JUBILEE MISSION MEDICAL COLLEGE AND RESEARCH INSTITUTE, THRISSUR
Thrissur KERALA 680005 India |
Phone |
9846022336 |
Fax |
|
Email |
drpcr77@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Vijay Chanchal A B |
Designation |
PG RESIDENT |
Affiliation |
JUBILEE MISSION MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Address |
DEPARTMENT OF EMERGENCY MEDICINE, JUBILEE MISSION MEDICAL COLLEGE AND RESEARCH INSTITUTE, THRISSUR
Thrissur KERALA 680005 India |
Phone |
9496866775 |
Fax |
|
Email |
v4vijay007@gmail.com |
|
Source of Monetary or Material Support
|
JUBILEE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
|
Primary Sponsor
|
Name |
Jubilee Centre for Medical Research |
Address |
JUBILEE MEDICAL COLLEGE AND RESEARCH INSTITUTE, THRISSUR 680005 |
Type of Sponsor |
Private medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
VIJAY CHANCHAL A B |
JUBILEE MISSION MEDICAL COLLEGE AND RESEARCH INSTITUTE |
DEPARTMENT OF EMERGENCY MEDICINE, JUBILEE MISSION MEDICAL COLLEGE AND RESEARCH INSTITUTE, THRISSUR 680005 Thrissur KERALA |
9496866775
v4vijay007@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE, JUBILEE MISSION MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K922||Gastrointestinal hemorrhage, unspecified, (2) ICD-10 Condition: K920||Hematemesis, (3) ICD-10 Condition: K921||Melena, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
a. All patients presenting to ED with UGIB
b. Age more than 18 years of age |
|
ExclusionCriteria |
Details |
a. Patients not consenting to study
b. Patients with known haematological disorders
c. Patients in which endoscopy or blood transfusion is done |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Primary outcome
o Predictive accuracy of addition of RDW to AIMS65 SCORE for determining the
30 day mortality in patients presenting to the ED with symptoms of UGIB. |
30 DAYS |
|
Secondary Outcome
|
Outcome |
TimePoints |
Secondary outcome :
o Predictive accuracy of addition of RDW to AIMS65 SCORE for determining the
a)need for blood transfusion
b)need for endoscopic intervention
c)need for surgical intervention
d)need for invasive ventilation
e)incidence of rebleeding
in patients presenting to the ED with symptoms of UGIB |
30 DAYS |
|
Target Sample Size
|
Total Sample Size="154" Sample Size from India="154"
Final Enrollment numbers achieved (Total)= "348"
Final Enrollment numbers achieved (India)="348" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/04/2019 |
Date of Study Completion (India) |
31/03/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NONE YET |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Acute upper gastrointestinal bleeding is a common presentation in emergency departments around the world. The incidence of UGIB is approximately 100 cases per 100000 population per year. Mortality rates are approximately 6-10% overall. Due to the high morbidity and mortality associated with UGIB, the emergency physician is challenged to promptly diagnose, accurately assess risk, and aggressively resuscitate patients with gastrointestinal bleeding within the confines of the emergency department. In UGIB patients, early risk stratification allows appropriate treatment and early endoscopy that may help in reducing morbidity and mortality. Many clinical factors, including patient’s age, gender, comorbid illnesses, medications, mental status and vital signs at the time of presentations, together with laboratory parameters such as haemoglobin, blood urea nitrogen, albumin and INR levels, are known to be associated with a high risk of morbidity and mortality. Many risk stratification scores have been developed over past couple of decades to predict the outcome and perform risk stratification in patients presenting with symptoms of UGIB. These include BLEED criteria, Rockall score, Glasgow Blatchford Score (GBS) and recently, AIMS65 score. Among these, AIMS65 score, was found to be a simple, easy to calculate risk assessment score to predict in-hospital mortality, length of hospital stay, and health care costs in patients with acute UGIB. The AIMS65 consists of the following components: albumin level <3.0 g/dL (A), INR >1.5 (I), altered mental status (M), systolic blood pressure ≤90 mm Hg (S), and age >65 years (65). A study from Saltzman et al showed the AIMS65 score to be superior to the GBS in predicting inpatient mortality from UGIB. Red-cell distribution width (RDW), a routine component of hemogram, represents the variability in size of circulating erythrocytes. This measure has been usually used to differentiate the etiology of anaemia. Some recent studies have reported that RDW has relationship with recurrent or massive bleeding in critical conditions, like intracranial hematoma, post-percutaneous coronary intervention and also in trauma. There have not been much studies comparing the relationship between RDW and upper GI bleed. After extensive literature search, we couldn’t identify any previous study evaluating the predictive ability of addition of RDW values to AIMS65 score and its use in risk stratification. The rationale of this studyin UGIB patients is to assess whether the prediction of mortality and morbidity using AIMS65 score improves when used in combination with RDW. |