| CTRI Number |
CTRI/2025/02/080193 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical and Endoscopic Evaluation of Patients Presenting with Acute Upper Gastrointestinal Bleeding |
|
Scientific Title of Study
|
Study of clinical and endoscopic profile of patients with acute upper GI bleed |
| 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 Sourab Arora |
| Designation |
Junior Resident,General medicine |
| Affiliation |
DY PATIL hospital,Navi Mumbai |
| Address |
Department of General Medicine Dr D Y Patil Medical College ,Navi Mumbai
Thane
MAHARASHTRA
400706
India
Thane
MAHARASHTRA
400706
India |
| Phone |
9888302803 |
| Fax |
|
| Email |
Sourab98a@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Shetty |
| Designation |
Professor |
| Affiliation |
DY PATIL hospital,Navi Mumbai |
| Address |
Department of General Medicine Dr D Y Patil Medical College ,Navi Mumbai
Thane
MAHARASHTRA
400706
India
Thane
MAHARASHTRA
400706
India |
| Phone |
9833991811 |
| Fax |
|
| Email |
Shettyvarun81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sourab Arora |
| Designation |
Resident,General medicine |
| Affiliation |
DY PATIL hospital,Navi Mumbai |
| Address |
Department of General Medicine Dr D Y Patil Medical College ,Navi Mumbai
Thane
MAHARASHTRA
400706
Indi
Thane
MAHARASHTRA
400706
India |
| Phone |
9888302803 |
| Fax |
|
| Email |
Sourab98a@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D Y Patil Medical College and Hospital,Nerul ,Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
DrSourab Arora |
| Address |
Junior Resident Department of General Medicine Dr D Y Patil Medical
College Navi Mumbai 400706 |
| Type of Sponsor |
Other [Primary investigator] |
|
|
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 Sourab Arora |
D.Y Patil Medical college,Navi mumbai |
OPD-1 (General Medicine OPD ) ,OPD -8
(GastrologyOPD ),Female Medicine Ward
,Male Medicine ward ,IIntensive Care Unit
,Dr D Y Patil Hospital Nerul,Navi Mumbai
,Maharashtra 400706
Thane
MAHARASHTR
Thane
MAHARASHTRA |
9888302803
sourab98a@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K920||Hematemesis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: adults aged 18 and above.
2. Acute upper GI bleed: Patients presenting with signs and symptoms of acute upper
GI bleeding, which may include hematemesis (vomiting of blood), melena (dark,
tarry stools), or hematochezia (passage of fresh blood through the rectum).
3. Confirmed diagnosis: Patients with a confirmed diagnosis of acute upper GI bleeding
based on clinical evaluation and diagnostic tests.
4. Endoscopy: Patients who have undergone upper GI endoscopy as part of their
diagnostic evaluation.
|
|
| ExclusionCriteria |
| Details |
Chronic GI bleeding: Patients with chronic or recurrent GI bleeding rather than acute bleeding.
2. Non-upper GI bleed: Patients with lower GI bleeding (e.g., colonic or rectal bleeding) rather than upper GI bleeding.
3. Known bleeding disorders: Patients with known bleeding disorders or coagulopathies that may affect the presentation or management of acute upper GI bleeding.
4. Previous upper GI surgery: Patients who have undergone previous upper GI surgery, as this may affect the endoscopic findings or clinical profile.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the frequency and distribution of different etiologies of acute UGIB.
2. To assess the presenting symptoms and signs of acute UGIB.
3. To determine the severity of acute UGIB using clinical and laboratory parameters.
4. To describe the endoscopic findings in patients with acute UGIB.
5. To assess the outcomes of patients with acute UGIB, including rebleeding, need for transfusion, need for endoscopic or surgical intervention, length of hospital stay, and mortality.
|
Baseline 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1-Two month follow-up recurrence |
Baseline 1 year |
|
|
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)
|
24/02/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This cross-sectional study aims to analyze the clinical and endoscopic profile of 100 patients presenting with acute upper gastrointestinal bleeding (UGIB) in a tertiary care hospital. By evaluating patient characteristics, endoscopic findings, and outcomes, the study will provide valuable insights into the diagnosis and management of UGIB. The results will help enhance clinical decision-making, improve patient outcomes, and potentially guide future research and practice guidelines in UGIB management.
|