| CTRI Number |
CTRI/2018/01/011220 [Registered on: 10/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
05/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Health status after physical injury |
|
Scientific Title of Study
|
A study to assess the health related outcome of trauma patients in a tertiary care trauma center |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Latha T |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education Manipal |
| Address |
Manipal College of Nursing Manipal
Manipal Academy of Higher Education Manipal
Udupi
Karnataka
Manipal College of Nursing Manipal
Manipal Academy of Higher Education Manipal
Udupi
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
latharadhakrishna@gmail.con |
|
Details of Contact Person
Scientific Query
|
| Name |
Latha T |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education Manipal |
| Address |
Manipal College of Nursing Manipal
Manipal Academy of Higher Education Manipal
Udupi
Karnataka
Manipal College of Nursing Manipal
Manipal Academy of Higher Education Manipal
Udupi
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
latharadhakrishna@gmail.con |
|
Details of Contact Person
Public Query
|
| Name |
Latha T |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education Manipal |
| Address |
Manipal College of Nursing Manipal
Manipal Academy of Higher Education Manipal
Udupi
Karnataka
Manipal College of Nursing Manipal
Manipal Academy of Higher Education Manipal
Udupi
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
latharadhakrishna@gmail.con |
|
|
Source of Monetary or Material Support
|
| Self (No funding received) |
|
|
Primary Sponsor
|
| Name |
Manipal College of Nursing Manipal |
| Address |
Manipal College of Nursing Manipal |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Nil |
Nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Latha T |
Kasturba Hospital Manipal |
Trauma Triage, Emergency Triage and Department of Orthopedics
Kasturba Hospital Manipal
Udupi
KARNATAKA |
9886398574
latharadhakrishna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Hospial, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
With traumatic injury, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient with immediate (within 48 hours) trauma will be included
All the patients treated in the trauma triage will be included
|
|
| ExclusionCriteria |
| Details |
Treated out side hospital |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Incidence of trauma admission and emergency surgeries
2. rate of trauma related death and physical disability
3.Identify and compare the complications of trauma
4. The infection rate |
At the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Health related trauma out come |
At the end of the study |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
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)
|
01/01/2018 |
| 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) |
Open to Recruitment |
|
Publication Details
|
Study has not started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Yet to start the study |