| CTRI Number |
CTRI/2024/06/069484 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Convenient sampling technique |
| Study Design |
Other |
|
Public Title of Study
|
Risk factors and prognosis of adult patients presenting with bleeding from upper gastrointestinal tract |
|
Scientific Title of Study
|
Profile and outcome of adult patients presenting to the Emergency Medicine department with upper gastrointestinal bleeding |
| 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 Bhuvneshwari Jaitawat |
| Designation |
Resident Doctor |
| Affiliation |
J.L.N Medical College and Hospital Ajmer |
| Address |
Department of Emergency Medicine J.L.N Medical College and Hospital ,Ajmer Rajasthan-305001
Ajmer
RAJASTHAN
305001
India
Ajmer
RAJASTHAN
305001
India |
| Phone |
9351177959 |
| Fax |
|
| Email |
bhuvneshwari.j22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Jain |
| Designation |
Head of Department |
| Affiliation |
J.L.N Medical College and Hospital Ajmer |
| Address |
Department of Emergency Medicine
J.L.N Medical College and Hospital , Ajmer Rajasthan-305001
Ajmer
RAJASTHAN
305001
India
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
vinodkanwar6191@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Jain |
| Designation |
Head of Department |
| Affiliation |
J.L.N Medical College and Hospital Ajmer |
| Address |
Department of Emergency Medicine
J.L.N Medical College and Hospital , Ajmer Rajasthan-305001
Ajmer
RAJASTHAN
305001
India
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
vinodkanwar6191@gmail.com |
|
|
Source of Monetary or Material Support
|
| J.L.N Medical College and Hospital , Ajmer , Rajasthan , India-305001 |
|
|
Primary Sponsor
|
| Name |
JLN Medical College and Hospital |
| Address |
J.L.N Medical College and Hospital , Ajmer , Rajasthan , India-305001 |
| Type of Sponsor |
Government medical college |
|
|
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 Bhuvneshwari Jaitawat |
J.L.N Medical College and Hospital |
Department of Emergency Medicine J.L.N Medical College and Hospital, Ajmer , Rajasthan-305001
Ajmer
RAJASTHAN |
9351177959
bhuvneshwari.j22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee J.L.N Medical College Ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K922||Gastrointestinal hemorrhage, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients coming to the emergency department with suspected upper gastrointestinal bleeding with the complaints of hematemesis and/or melena and/or hematochezia |
|
| ExclusionCriteria |
| Details |
Patients with suspected/confirmed traumatic upper gastrointestinal bleeding
Patients who had previously been enrolled in the study who presented with recurrent episode of upper gastrointestinal bleed |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To describe the proportion, clinical characteristics and ED management strategies of patients presenting with upper gastrointestinal bleeding |
24 HRS
48 HRS
72 HRS
96 HRS
120 HRS
144 HRS
168 HRS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the in-hospital mortality rates and factors associated with mortality amongst patients presenting with upper gastrointestinal bleeding |
zero time at the time of admission
24 hour
48 hour
72 hour
96 hour
120 hour
144 hour
168 hour |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
06/07/2024 |
| 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)
|
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
|
In this study we will describe the proportion , clinical characteristics, ED management strategies , in-hospital mortality and factors associated with mortality of adult patients aged between 18-60 years presenting in the emergency department with upper gastrointestinal bleeding. We will also see if early endoscopy within 24 hrs of presentation of the patient has any effect on the morbidity and mortality of the patient. |