| CTRI Number |
CTRI/2018/12/016496 [Registered on: 03/12/2018] Trial Registered Prospectively |
| Last Modified On: |
31/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A survey of various factors and outcome of trauma patients |
|
Scientific Title of Study
|
Clinico-epidemiological study of patients with trauma admitted to trauma and emergency medicine department of AIIMS Bhubaneswar |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Reference No: T/IM-NF/T&EM/17/31 17/02/2018 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chitta Ranjan Mohanty |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Science Bhubaneswar |
| Address |
Department of Trauma and Emergency
All India Institute of Medical Science Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884046 |
| Fax |
|
| Email |
tem_chitta@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitta Ranjan Mohanty |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Science Bhubaneswar |
| Address |
Department of Trauma and Emergency
All India Institute of Medical Science Bhubaneswar
ORISSA
751019
India |
| Phone |
9438884046 |
| Fax |
|
| Email |
tem_chitta@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chitta Ranjan Mohanty |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Science Bhubaneswar |
| Address |
Department of Trauma and Emergency
All India Institute of Medical Science Bhubaneswar
ORISSA
751019
India |
| Phone |
9438884046 |
| Fax |
|
| Email |
tem_chitta@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science, Bhubaneswar.
Sijua,Pin-751019
Orissa,India |
|
|
Primary Sponsor
|
| Name |
Dr Chitta Ranjan Mohanty |
| Address |
Department of Trauma and Emergency
All India Institute of Medical Science
Bhubaneswar
751019 |
| Type of Sponsor |
Other [Principal 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 Chitta Ranjan Mohanty |
All India Institute of Medical Science Bhubaneswar |
Department of Trauma and Emergency
G-Block
Ground Floor
Khordha
ORISSA |
9438884046
tem_chitta@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE All India Institute of Medical Science Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V892||Person injured in unspecified motor-vehicle accident, traffic, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All trauma patients admitted to the department of trauma and emergency AIIMS Bhubaneswar.
2. Duration of stay more than six hours. |
|
| ExclusionCriteria |
| Details |
1. Refusal to give consent.
2. Not able to comprehend questions and not accompanied by caregivers who can give full information.
3. Patients admitted after being referred from any other healthcare facility. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Epidemiological and clinical profile of trauma patients admitted to trauma and emergency department. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pathway of care.
2. Mortality.
|
7 days |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "502"
Final Enrollment numbers achieved (India)="502" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/12/2018 |
| Date of Study Completion (India) |
29/08/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This Prospective observational study will be carried out in the department of trauma and emergency of All India Institute of Medical science Bhubaneswar which is a level-1 trauma center over a period of one year. Epidemiological profile of patients will be recorded as per case record format. Clinical assessment as per advanced trauma life support guideline and recorded in the case recorded format. |