| CTRI Number |
CTRI/2025/10/095579 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Using routine blood test to forecast functional outcomes in head injury patients following road traffic accidents |
|
Scientific Title of Study
|
Systemic inflammatory markers in predicting poor neurological outcomes following moderate and severe traumatic brain injury. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SEHAM SYEDA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
M S Ramaiah Medical College and Hospitals |
| Address |
Department of Anesthesiology,
M S Ramaiah Medical College and Hospitals ,
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9886094357 |
| Fax |
|
| Email |
sehamsyeda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SEHAM SYEDA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
M S Ramaiah Medical College and Hospitals |
| Address |
Department of Anesthesiology,
M S Ramaiah Medical College and Hospitals ,
Bangalore
KARNATAKA
560054
India |
| Phone |
9886094357 |
| Fax |
|
| Email |
sehamsyeda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SEHAM SYEDA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
M S Ramaiah Medical College and Hospitals |
| Address |
Department of Anesthesiology,
M S Ramaiah Medical College and Hospitals ,
Bangalore
KARNATAKA
560054
India |
| Phone |
9886094357 |
| Fax |
|
| Email |
sehamsyeda@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
M S Ramaiah Medical College and Hospitals |
| Address |
M S Ramaiah Medical College ,
M S Ramaiah Nagar, MSRIT post,
Bangalore-560054 |
| 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 Seham Syeda |
Ramaiah Memorial Hospital |
Neurocritical care unit, M S Ramaiah Institute of Neurosciences
Bangalore
KARNATAKA |
9886094357
sehamsyeda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramaiah Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S060||Concussion, (2) ICD-10 Condition: S062||Diffuse traumatic brain injury, (3) ICD-10 Condition: S064||Epidural hemorrhage, (4) ICD-10 Condition: S061||Traumatic cerebral edema, (5) ICD-10 Condition: S066||Traumatic subarachnoid hemorrhage, (6) ICD-10 Condition: S065||Traumatic subdural hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years
Diagnosed with moderate and severe TBI with GCS less than 13
Presenting within 24 hours of injury
Complete Blood Count and Liver Function Test available |
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Preadmission immunomodulatory therapy
Severe polytrauma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| GOSE- Glasgow Outcome Score Extended |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. ICU stay duration
2.Hospital stay duration
3.GCS at discharge
|
At discharge from hospital |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
20/10/2025 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Traumatic brain injury is a leading cause of mortality and morbidity worldwide. Accurate prognostication of these patients is of paramount importance in order to counsel family members , to guide clinical decisions and proper resource allocation in a developing country like India. Systemic inflammation and Immune regulation play an important role in pathophysiology of TBI. Neutrophil - Lymphocyte Ratio (NLR), Platelet- Lymphocyte Ratio (PLR) and Neutrophil - Albumin Ratio (NAR) are reflective of the balance between the two. We hypothesise that an elevation of these ratios in the first 24 hours following TBI correlates with poor prognosis as evaluated using Glasgow Outcome Score Extended (GOSE). Hence we designed this comprehensive study using these inexpensive and routinely available haematological markers . |