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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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.
 
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