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
|
|
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
|
|
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
|
|
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. |