| CTRI Number |
CTRI/2020/12/029465 [Registered on: 01/12/2020] Trial Registered Prospectively |
| Last Modified On: |
08/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Profile(Description) and Clinical outcome(measurable changes in health) of trauma patients in Emergency Medicine department: A prospective single tertiary care centered study. |
|
Scientific Title of Study
|
Profile and Clinical outcome of trauma patients in Emergency Medicine department: A prospective single tertiary care centered study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjeev Kumar |
| Designation |
Professor, Department of Anaesthesiology, IGIMS, Patna. |
| Affiliation |
IGIMS, Patna |
| Address |
Department of Anaesthesiology and Critical Care, Besides Neuro OT complex, IGIMS, Patna.
Patna
BIHAR
800014
India |
| Phone |
9473191829 |
| Fax |
|
| Email |
sanjeev_pranay71@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjeev Kumar |
| Designation |
Professor, Department of Anaesthesiology, IGIMS, Patna. |
| Affiliation |
IGIMS, Patna |
| Address |
Department of Anaesthesiology and Critical Care, Besides Neuro OT complex, IGIMS, Patna.
Patna
BIHAR
800014
India |
| Phone |
9473191829 |
| Fax |
|
| Email |
sanjeev_pranay71@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjeev Kumar |
| Designation |
Professor, Department of Anaesthesiology, IGIMS, Patna. |
| Affiliation |
IGIMS, Patna |
| Address |
Department of Anaesthesiology and Critical Care, Besides Neuro OT complex, IGIMS, Patna.
Patna
BIHAR
800014
India |
| Phone |
9473191829 |
| Fax |
|
| Email |
sanjeev_pranay71@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Patna. |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute Of Medical Sciences Patna |
| Address |
Sheikhpura, Patna - 800014 |
| 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 |
| Sanjeev Kumar |
Indira Gandhi Institute Of Medical Sciences, Patna |
Department of Emergency Medicine , Indira Gandhi Institute Of Medical Sciences , Patna, Bihar.
Patna
BIHAR |
9473191829
sanjeev_pranay71@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGIMS,Patna. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of trauma through road traffic accident, industrial accident, Electrical injury, Fall from height and trauma related to assault, sports and animals. |
|
| ExclusionCriteria |
| Details |
Refusal from the patient, patient who are dead on arrival in ICU and Non-trauma patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the profile and Clinical outcome of trauma patients admitted in the Emergency Medicine department of IGIMS, Patna. |
After admission, severity of injuries, physiological variables, Glasgow Coma scale will be recorded. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine effective prevention and comprehensive management strategies of Trauma patients admitted in ICU. |
The outcome of patients in ICU will be recorded before discharge of the patients. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/12/2020 |
| 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
|
Plan to publish after Completion of the Study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study is to study profile and Clinical outcome of trauma patients who are admitted in Emergency Medicine department so that effective prevention and comprehensive management strategies could be made. |