| CTRI Number |
CTRI/2024/08/072987 [Registered on: 27/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To observe the utility of prehospital scoring tools in predicting outcomes in trauma patients. |
|
Scientific Title of Study
|
Comparing Outcome Prediction Using Pre-hospital Trauma Scoring Systems In Adult Polytrauma Patients Presenting To The Emergency Department |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krithika |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions MAHE |
| Address |
Department of Emergency Medical Technology Manipal College of Health Professions MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9353215382 |
| Fax |
|
| Email |
krithika.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vimal Krishnan Surendran Pillai |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Emergency Medicine Kasturba Medical College and Hospital MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9995389984 |
| Fax |
|
| Email |
vimal.krishnan@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vimal Krishnan Surendran Pillai |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Emergency Medicine Kasturba Medical College and Hospital MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9995389984 |
| Fax |
|
| Email |
vimal.krishnan@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Emergency Medicine, Kasturba Medical College, Manipal, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India. Pin-576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal Academy of Higher Education |
| Address |
Kasturba Medical College and Hospital Madhava Nagar Manipal Udupi Karnataka 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vimal Krishnan Surendran Pillai |
Kasturba Hospital Manipal |
Department of Emergency Medicine Kasturba Medical College Manipal Academy of Higher Education
Udupi
KARNATAKA |
9995389984
vimal.krishnan@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years or older
Patients with confirmed and suspected polytrauma presenting within 24 hours |
|
| ExclusionCriteria |
| Details |
Patients Leaving Against Medical Advice (LAMA) from the Emergency Department |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determining mortality |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determining the duration of ICU stay duration of ventilatory support need for massive transfusion need for hemodialysis and total length of hospital stay |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
04/09/2024 |
| 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
|
The study will be conducted after obtaining IRC and IEC approval and CTRI registration. After IRC , IEC and CTRI registration. The study will be explained to the subjects if conscious and coherent, and informed consent will be obtained. If the subject is unconscious, the study will be explained to the bystanders/legally authorized representative, and informed consent will be obtained. The data collection will be done in the resuscitation zone/blue area of the Emergency Department. Acquired data will be analyzed by JAMOVI statistics software version 2.4.11. |