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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  
Name  Address 
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 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S069||Unspecified intracranial injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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
 
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