| CTRI Number |
CTRI/2024/04/065900 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Predictive Value of Systemic Immune Inflammation Index in the prognosis of moderate to severe Traumatic Brain Injury patients: A prospective observational study |
|
Scientific Title of Study
|
Predictive Value of Systemic Immune Inflammation Index in the prognosis of moderate to severe Traumatic Brain Injury patients: A prospective observational 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 |
aditya raj yadav |
| Designation |
senior resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of anesthesia , neuroanesthesia division , 6th floor , office complex , AIIMS rishikesh , veerbhadra road , Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09130059299 |
| Fax |
|
| Email |
aditya.raj.yadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Gupta |
| Designation |
Additional professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of anesthesia , neuroanesthesia division , 6th floor , office complex , AIIMS rishikesh , veerbhadra Road, Rishikesh
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
drpriyankagupta84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
aditya raj yadav |
| Designation |
senior resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of anesthesia , neuroanesthesia division , 6th floor , office complex , AIIMS rishikesh , veerbhadra road , rishikesh ,
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09130059299 |
| Fax |
|
| Email |
aditya.raj.yadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Rishikesh, verbhadra road , Rishikesh , District - dehradun , uttranchal , India , pincode : 249203 |
|
|
Primary Sponsor
|
| Name |
AIIMS rishikesh |
| Address |
verbhadra road , rishikesh , India , pin code: 249203 |
| Type of Sponsor |
Government 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 Aditya raj yadav |
AIIMS Rishikesh |
department of anesthesia , 6th floor , ot complex, Aiims , verbhadra raod , rishikesh
Dehradun
UTTARANCHAL |
9130059299
aditya.raj.yadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Systemic Immune Inflammation Index (SII) |
platelets × neutrophils/lymphocytes index (SII) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with moderate to severe head injury (GCS ≤12)
Presented to the emergency ward within 24 hours of injury.
Patients with head injury findings on the first non-contrast computer tomography (NCCT) brain.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the predictive value of SII index for prognosis in Traumatic brain injury taking GOSE score of 5-8 as favourable prognosis. |
GOSE score will be assessed at discharge and at 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare and analyse the values of SII and NLR,PLR and LMR within 24 hours and 3rd day of head injury |
first blood sample within 24 hours and 3rd day of admission. |
| To assess the order of importance(ranking) of SII index, NLR, PLR and LMR for prediction of TBI patients prognosis. |
not applicable. |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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)
|
25/04/2024 |
| 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 Yet Recruiting |
| 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
|
This prospective observational study, will be conducted
at the department of neuroanesthesia at AIIMS Rishikesh, aims to assess the
predictive value of the SII index in Traumatic Brain Injury, with a particular
focus on patients who have a positive prognosis, which is defined as a GOSE
score of 5-8. The parameters examined
consist of the values of Systemic Inflammatory Index (SII) and Neutrophil-to-Lymphocyte
Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), and Lymphocyte-to-Monocyte
Ratio (LMR), which will be recorded within 24 hours and on the 3rd day
following a head injury. In addition, we will assess the comparative
significance (hierarchy) of the SII index, NLR, PLR, and LMR in forecasting the
prognosis of TBI patients. Over a period of 1 year, approximately 142
patients who match the specified inclusion criteria will be enrolled for the
study. Patients will be treated following the established institutional
protocol and recognized standards of care. |