| CTRI Number |
CTRI/2021/09/036842 [Registered on: 24/09/2021] Trial Registered Prospectively |
| Last Modified On: |
08/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of scoring systems head injury
|
|
Scientific Title of Study
|
FOUR Score in predicting the severity and outcome of Traumatic Brain Injury (TBI)
compared to GCS
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aravind V |
| Designation |
DNB Emergency Medicine Resident |
| Affiliation |
MOSC Medical college hospital, Kolenchery,Ernakulam |
| Address |
Department of Emergency Medicine, MOSC Medical College Hospital, Kolenchery
Ernakulam KERALA 682311 India |
| Phone |
8281277543 |
| Fax |
|
| Email |
aravindmanu007@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mariamma Kuriakose |
| Designation |
Consultant |
| Affiliation |
MOSC Medical College Hospital, Kolenchery, Ernakulam |
| Address |
Department of Emergency Medicine, MOSC Medical College Hospital, Kolenchery, Ernakulam
682311
Ernakulam KERALA 682311 India |
| Phone |
9446519630 |
| Fax |
|
| Email |
lisamma1@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
ARAVIND V |
| Designation |
DNB Emergency medicine resident |
| Affiliation |
MOSC Medical College Hospital, Kolenchery, Ernakulam |
| Address |
Department of Emergency Medicine, MOSC Medical College Hospital, Kolenchery, Ernakulam
682311
Ernakulam KERALA 682311 India |
| Phone |
8281277543 |
| Fax |
|
| Email |
aravindmanu007@gmail.com |
|
|
Source of Monetary or Material Support
|
| MOSC Medical College Hospital, Kolenchery, Ernakulam
682311 |
|
|
Primary Sponsor
|
| Name |
MOSC Medical College Hospital |
| Address |
Department of Emergency Medicine, MOSC Medical College Hospital, Kolenchery, Ernakulam
682311 |
| Type of Sponsor |
Private 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 |
| Dr Aravind V |
MOSC Medical College,Kolenchery |
Department of Emergency Medicine, Department of Neurosurgery , Neurosurgery ICU
Ernakulam KERALA |
8281277543
aravindmanu007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,Malankara Orthodox Syrian Church Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
98.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients above 18 years of age sustained TBI
2. Documented brain injury in CT scan
|
|
| ExclusionCriteria |
| Details |
1. Patients sustained with non-traumatic brain injury
2. Those with documented pre-existing neurologic deficit
3.Patients with injuries other than TBI which interferes with
outcome |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nourological outcome which will be measured using GOS-E(Glasgow outcome scale extended) r unfavorable (score 1-4) or favorable (score5-8) |
At the end of 1st and 3rd month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| In hospital mortality and ICU length of stay |
At the time of discharge |
|
|
Target Sample Size
|
Total Sample Size="138" Sample Size from India="138"
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)
|
01/10/2021 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Traumatic brain
injury is one of the leading causes of death and disability in patients
admitted to the emergency department. The Glasgow Coma Scale (GCS) is the
most widely accepted scale for assessing levels of consciousness, clinical
status, as well as prognosis of traumatic brain injury (TBI) patients. The Full
Outline of UnResponsiveness (FOUR) score is a new coma scale developed
addressing the limitations of the GCS.
In this context this study aims to compare Four Score in predicting the severity
and outcome of Traumatic Brain Injury (TBI) compared to GCS. By choosing
the best assessment methods, needed interventions can be made early and can be
life saving to the patient.GCS and FOUR score will be recorded during the primary
assessment in the ER followed by 24 hours post presentation. The FOUR score and
GCS will be compared to the Marshall classification to find out which one
correlates with severity of injury better. Data regarding usage of anti
platelets/anti coagulants prior to Traumatic brain injury will be collected. It
will be compared to outcome to know if it interferes with outcome of TBI. GCS
scoring includes eye opening, verbal and motor response for the assessment of
severity of TBI. The primary outcomes will be measured
using Glasgow outcome scale extended. Patients will be prospectively followed up and score will be recorded in
Glasgow outcome scale extended (GOSE) at1 month and 3 month via telephone/face to face interview.
Details collected includes data to analyze mortality and level of disability
due to the TBI. GOSE 1 (dead), GOSE 2 (vegetative state), GOSE 3 (lower severe
disability), GOSE 4 (upper severe disability), GOSE 5 (lower moderate
disability), GOSE 6(upper moderate disability), GOSE 7 (lower good recovery), and
GOSE 8 (upper good recovery). Our study tool will be a pre structured proforma
and it consists clinical evaluations and
diagnostic part.
The final outcomes will be decided either
unfavorable (score 1-4) or favorable (score5-8).5 In hospital
mortality and ICU length of stay will be assessed during this study. Patients
with other severe injuries other than traumatic brain injury will be excluded
from the study if it is found to interfere with outcome at any stage of the
study |