| CTRI Number |
CTRI/2024/11/076212 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the usefullness of IMPACT & CRASH outcome prediction scores for
traumatic brain injury: to predict outcome in Indian population |
|
Scientific Title of Study
|
Use of IMPACT & CRASH prognostication models for
traumatic brain injury: to predict outcome in Indian population, a pilot study, |
| 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 Emy Ambooken |
| Designation |
DrNB trainee |
| Affiliation |
Kovai Medical Centre and Hospital,Coimbatore |
| Address |
DrNB - Department of Critical Care Medicine
Kovai Medical Center and Hospital, Avinashi Road,
Coimbatore - 641014.
Coimbatore
TAMIL NADU
641014
India |
| Phone |
09809750033 |
| Fax |
|
| Email |
emyambooken@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopinathan T |
| Designation |
HOD |
| Affiliation |
Kovai Medical Centre and Hospital,Coimbatore |
| Address |
Department of Critical Care Medicine,Kovai Medical centre and Hospital
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9790832509 |
| Fax |
|
| Email |
docgopi79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Emy Ambooken |
| Designation |
DrNB trainee |
| Affiliation |
Kovai Medical Centre and Hospital,Coimbatore |
| Address |
DrNB - Department of Critical Care Medicine
Kovai Medical Center and Hospital, Avinashi Road,
Coimbatore - 641014.
Coimbatore
TAMIL NADU
641014
India |
| Phone |
09809750033 |
| Fax |
|
| Email |
emyambooken@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kovai Medical Center and Hospital |
| Address |
Kovai Medical centre and Hospital
,Avinashi Road,Coimbatore,Tamil NAdu,India
Coimbatore
Pin:641014 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Emy Ambooken |
Kovai Medical Centre and Hospital,Coimbatore |
DrNB - Department of Critical Care Medicine
Kovai Medical Center and Hospital, Avinashi Road,
Coimbatore - 641014.
Coimbatore
TAMIL NADU |
9809750033
emyambooken@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCH ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil as it is an observational study |
| Comparator Agent |
Nil |
Nil as it is an observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted with a diagnosis of traumatic brain injury with a
GCS of 12 or less |
|
| ExclusionCriteria |
| Details |
1. Hospital admission more than 6 hours post trauma.
2. Patients less than 18 years of age
3. Pregnant patients
4. GCS score affected by the presence of alcohol or drugs of abuse
5. GCS score of three with bilateral fixed and dilated pupils, or if
their injury was believed to be non-salvageable.
6. Those patients with a pre-existing neurological disability that
would not allow follow-up
7. Those patients without adequate data records |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To calculate the 6-month mortality and unfavorable outcome as predicted by IMPACT model and CRASH model and to compare with the observed 6-month mortality and unfavourable as seen in those patients with moderate to severe traumatic brain injury patients.
|
at 6 months after TBI |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To calculate 14-day mortality and 6-month unfavourable
outcome as predicted by CRASH model with CT and without
CT and compare with the observed 14-day mortality and 6
month unfavourable outcome in moderate to severe traumatic
brain injury patients |
6 months after TBI |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "376"
Final Enrollment numbers achieved (India)="376" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2024 |
| Date of Study Completion (India) |
30/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/04/2025 |
|
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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a retrospective observational study to evaluate ability of IMPACT and CRASH TBI model in predicting six month outcome in moderate to severe TBI patients in middle and low income countries.Records of patients admitted with moderate to severe TBI with GCS less than or equal to 12 during time period from january 2021 to june 2024 and satisfying inclusion criteria will be included in the study.Records of those patients will be retrieved and data like age,motor response,pupillary response at admission,existence of prehospital hypoxia,development of hypotension,marshall CT classification and presence of major extracranial injury based on abbreviated injury score will be collected and based on these variables IMPACT model and CRASH model will be used to predict their six month outcome.Glassgow Outcome Scale (GOS) of these patients will be assesed at their routine follow up visit after six months of TBI or by telephonic interview.Glassgow Outcome Scale will be dichotomized as favourable (GOS 4 to 5) VS unfavourable (GOS 1 to 3) vs Mortality (GOS 1).The prognostic ability of IMPACT and CRASH model in predicting 6 months outcome will be assesed using appropriate statiscal model. |