| CTRI Number |
CTRI/2025/09/094236 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive / Analytical |
| Study Design |
Other |
|
Public Title of Study
|
A Study on Patients with Upper Gastrointestinal Bleeding: Causes, Patterns, and Recovery |
|
Scientific Title of Study
|
Evaluation of Clinical and Demographic Profiles and Outcomes in Patients with Upper Gastrointestinal Bleeding: a prospective observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Darshil Khared |
| Designation |
Junior Resident Doctor |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Datta Meghe Institute of Higher Education & Research, (Deemed to be University), Sawangi (Meghe), Wardha - 442107, Maharashtra, India
Wardha
MAHARASHTRA
442107
India |
| Phone |
9879727398 |
| Fax |
|
| Email |
dr.darshilkhared@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditya Pundkar |
| Designation |
Professor & Head, Department of Emergency Medicine |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Datta Meghe Institute of Higher Education & Research, (Deemed to be University), Sawangi (Meghe), Wardha - 442107, Maharashtra, India.
Wardha
MAHARASHTRA
442107
India |
| Phone |
9975170898 |
| Fax |
|
| Email |
draditya.pundkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshil Khared |
| Designation |
Junior Resident Doctor |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Datta Meghe Institute of Higher Education & Research, (Deemed to be University), Sawangi (Meghe), Wardha - 442107, Maharashtra, India.
Wardha
MAHARASHTRA
442107
India |
| Phone |
9879727398 |
| Fax |
|
| Email |
dr.darshilkhared@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education & Research,
(Deemed to be University), Sawangi (Meghe),
Wardha - 442107 Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Darshil Khared |
| Address |
Room No G5, Raghobaji PG Boys Hostel, Datta Meghe Institute of Higher Education & Research,
(Deemed to be University), Sawangi (Meghe),
Wardha - 442107 Maharashtra |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Datta Meghe Institute of Higher Education Research |
Datta Meghe Institute of Higher Education & Research, (Deemed to be University), Sawangi (Meghe), Wardha - 442107 Maharashtra |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Darshil Khared |
Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital |
Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe),Wardha.Maharashtra 442107
Wardha
MAHARASHTRA |
9879727398
dr.darshilkhared@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education & Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K920||Hematemesis, (2) ICD-10 Condition: K921||Melena, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged more then 18 years presenting to the Emergency Medicine Department with suspected or confirmed UGIB.
2. Patients presenting with hematemesis, melena, or both, or clinical suspicion of UGIB based on history and clinical examination.
3. Patients providing written informed consent (or proxy consent if critically ill, as per ethical guidelines).
|
|
| ExclusionCriteria |
| Details |
1. Patients with UGIB directly related to recent trauma.
2. Patients with UGIB directly related to poisoning.
3. Patients previously enrolled in the study presenting with recurrent UGIB during the study period.
4. Patients transferred from another facility with prior definitive UGIB management (e.g., endoscopy or surgery) before ED arrival.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To Describe Clinical Profile of patients presenting with Upper Gastrointestinal bleeding.
2. To assess Demographic Profile of patients presenting with Upper Gastrointestinal bleeding.
3. To Evaluate Outcomes in Upper Gastrointestinal bleeding patients.
|
18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To identify key Risk Factors associated with Upper Gastrointestinal bleeding |
18 Months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary Purpose of the Protocol
The primary purpose of this study is to evaluate the clinical presentations, demographic characteristics, and outcomes of adult patients presenting with upper gastrointestinal bleeding (UGIB) to the Emergency Department of a tertiary care hospital in rural Maharashtra. By assessing clinical profiles, risk factors, and outcomes, the study aims to provide region-specific data relevant to a predominantly rural population, thereby improving early diagnosis, risk stratification, and management strategies.
Study Hypothesis
It is hypothesized that among patients from a largely rural population, specific demographic and clinical profiles such as advanced age, comorbidities, hemodynamic instability, and underlying etiology of bleeding are significantly associated with adverse outcomes. Recognition of these predictors will enable more effective risk stratification and outcome-oriented management in emergency settings. |