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CTRI Number  CTRI/2023/05/053156 [Registered on: 26/05/2023] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Using Bedside Ultrasound to diagnose cause of blood in vomitus 
Scientific Title of Study   UTILITY OF POINT OF CARE ULTRASOUND TO PREDICT VARICEAL ETIOLOGY IN PATIENTS WITH UPPER GASTROINTESTINAL HEMORRHAGE PRESENTING TO THE EMERGENCY DEPARTMENT 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Siddhi Naik 
Designation  Junior Resident  
Affiliation  Kasturba Medical College  
Address  Department of Emergency Medicine, Ground floor, Kasturba Medical College, Manipal, Udupi, Karnataka
Department of Emergency Medicine, Ground floor, Kasturba Medical College, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India 
Phone  9930476662  
Fax    
Email  siddhi.kmcmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prithvishree Ravindra 
Designation  Associate Professor  
Affiliation  Kasturba Medical College  
Address  Department of Emergency Medicine, Ground floor, Kasturba Medical College, Manipal, Udupi, Karnataka
Department of Emergency Medicine, Ground floor, Kasturba Medical College, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India 
Phone  9035296971  
Fax    
Email  prithvishree.r@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Siddhi Naik 
Designation  Junior Resident  
Affiliation  Kasturba Medical College  
Address  Department of Emergency Medicine, Ground floor, Kasturba Medical College, Manipal, Udupi, Karnataka
Department of Emergency Medicine, Ground floor, Kasturba Medical College, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India 
Phone  9930476662  
Fax    
Email  siddhi.kmcmpl2022@learner.manipal.edu  
 
Source of Monetary or Material Support  
Department of Emergency Medicine, Kasturba Medical College, Manipal, Udupi, Karnataka 
 
Primary Sponsor  
Name  Dr Siddhi Naik 
Address  Department of Emergency Medicine, Kasturba Medical College, Manipal, Udu[i, Karnataka 
Type of Sponsor  Other [self] 
 
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 
Dr Siddhi Naik  Kasturba Hospital   Department of Emergency Medicine, Ground floor, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA 
9930476662

siddhi.kmcmpl2022@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, (2) ICD-10 Condition: K270||Acute peptic ulcer, site unspecified, with hemorrhage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients presenting with upper GI Bleed.  
 
ExclusionCriteria 
Details  1. Patients not consenting to get enrolled in the study; 2. Patients not undergoing
UGI scopy.3. Patients who have portal vein thrombosis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Diagnosis of Varices on UGI Scopy   Point of care ultrasound done at admission to Emergency Department
Upper GI scopy report will be collected once UGI scopy completed (within 48hr) 
 
Secondary Outcome  
Outcome  TimePoints 
Comparing point of care ultrasound with laboratory markers to predict variceal etiology in patients
with upper gastrointestinal hemorrhage presenting to the Emergency Department. 
At admission 
 
Target Sample Size   Total Sample Size="184"
Sample Size from India="184" 
Final Enrollment numbers achieved (Total)= "181"
Final Enrollment numbers achieved (India)="181" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2023 
Date of Study Completion (India) 31/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/05/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Study will be sent for publication once completed  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Upper GI Hemorrhage is a common ED presentation which can often be life threatening. Massive bleeding can cause hypovolemia and shock. Hence, this requires expedited management. Upper GI hemorrhage can be Variceal or Non Variceal. Diagnosis of variceal bleed usually happens at Endoscopy. Early identification of variceal cause of GI bleed in ED will enable early initiation of octreotide/terlipressin and plan for Emergent UGI scopy. However, in the Emergency Department, diagnosis of Portal Hypertension and varices is challenging. Use of non-invasive predictors of varices including ultrasound parameters by radiologists have found promising results. But, such a study is lacking in the emergency setting. We would like to study if using a non-invasive, easily accessible, bedside POCUS will help us predict varices in patients presenting to the ED with UGI Hemorrhage. Patients who come to the Emergency Department with upper GI bleed, meeting the inclusion and exclusion criteria will be considered for the study. After taking informed consent, patients will be enrolled. The history and physical examination findings will be noted. Point of care ultrasound will be done measuring the portal vein diameter, portal vein patency and blood flow velocity, portal vein congestion index will be calculated. Splenic diameter will be noted.Details will be collected as per proforma. Laboratory markers as sent by treating clinician will be noted. No additional blood test will be sent other than as clinically indicated. No charge will be levied for the point of care ultrasound. All patients with upper gastrointestinal hemorrhage undergo upper GI scopy by gastroenterologist. The findings of the Upper GI scopy, the discharge diagnosis and outcome will be noted. Through this study, our objectives are 1. To assess Diagnostic accuracy of portal vein indices in point of care ultrasound to predict variceal etiology in patients with upper gastrointestinal hemorrhage presenting to the Emergency Department. 2.To compare point of care ultrasound with laboratory markers to predict variceal etiology in patients with upper gastrointestinal hemorrhage presenting to the Emergency Department.
 
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