| CTRI Number |
CTRI/2019/01/017223 [Registered on: 24/01/2019] Trial Registered Prospectively |
| Last Modified On: |
12/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Prediction of prognosis by GCS-Pupils score. |
|
Scientific Title of Study
|
Evaluation of the GCS-Pupils Score for prOgnosis in trauMatic brAin injury – The COMA Study
|
| Trial Acronym |
COMA study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Charu Mahajan |
| Designation |
Assistant Professor |
| Affiliation |
Dept. of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences (AIIMS) |
| Address |
Dept. of Neuroanaesthesiology and Critical Care, Neurosciences centre, All India Institute of Medical Sciences, New Delhi, India.
New Delhi
DELHI
110029
India |
| Phone |
91-7042132730 |
| Fax |
|
| Email |
charushrikul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Mahajan |
| Designation |
Assistant Professor |
| Affiliation |
Dept. of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, New delhi. |
| Address |
Dept. of Neuroanaesthesiology and Critical Care, Neurosciences centre, All India Institute of Medical Sciences (AIIMS), New Delhi
New Delhi
DELHI
110029
India |
| Phone |
91-7042132730 |
| Fax |
|
| Email |
charushrikul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charu Mahajan |
| Designation |
Assistant Professor |
| Affiliation |
Dept. of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, New Delhi. |
| Address |
Dept. of Neuroanaesthesiology and Critical Care, Neurosciences Centre, AIIMS, New Delhi, India.
New Delhi
DELHI
110029
India |
| Phone |
91-7042132730 |
| Fax |
|
| Email |
charushrikul@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Dept of Neuroanaesthesiology and Critical Care, Neurosciences Centre, AIIMS, New Delhi, India. |
| 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 |
| Charu Mahajan |
All India Institute of Medical Sciences (AIIMS), New Delhi |
Dept of Neuroanaesthesiology and Critical Care.
New Delhi
DELHI |
91-7042132730
charushrikul@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Committee |
Approved |
| AIIMS, Rishikesh, Institute Ethics Committee |
Approved |
| Institute Ethics Committee, Lokmanya Tilak Muncipal Medical College and General Hospital |
Approved |
| NIMHANS ethics commitee |
Approved |
| PGIMER, Chandigarh, Institute Ethics Committee |
Approved |
| Sanjay Gandhi Postgraduate Institute of medical Sciences,Institutional Ethics Committee |
Approved |
| Sher-I-Kashmir Institute of Medical Sciences, Institutional Ethics Committee, Srinagar. |
Approved |
| SMS Medical College and attached Hospitals,Ethics Committee,Jaipur. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S062||Diffuse traumatic brain injury, (2) ICD-10 Condition: S063||Focal traumatic brain injury, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (> 18 years) admitted to NICU within 12 hours of injury, following acute traumatic brain injury, penetrating or non-penetrating. |
|
| ExclusionCriteria |
| Details |
Age <18 years, non-traumatic acute brain injury such as stroke and subarachnoid hemorrhage, patients having eye/orbital injury in whom pupillary response cannot be assessed and patients not admitted to NICU.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glasgow outcome scale – extended (GOS-E) [at time of discharge from hospital and at 6 months post-injury] |
Glasgow outcome scale – extended (GOS-E) [at time of discharge from hospital and at 6 months post-injury] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
none |
|
|
Target Sample Size
|
Total Sample Size="1650"
Sample Size from India="1650"
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)
|
01/02/2019 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
As the GCS-pupils score retains the simplicity of original GCS while expanding the information about the severity of patient’s clinical status, we aim to assess and evaluate the role of this score in prognostication of patients having traumatic head injury. Our objectives of this study are to 1. to assess in patients with traumatic head injury, the relationship between GCS-P and outcome at 6 months and 2. to assess in patients with traumatic head injury, the relationship between GCS and outcome at 6 months. All patients above 18 years of age, admitted to neurointensive care unit within 12 hours of traumatic brain injury,will be included in the study. GCS and GCS-P score at admission will be noted along with demographics, surgical and intensive care management data. At 6 months, Outcome as assessed by GOS-E will be correlated with GCS and GCS-P. |