| CTRI Number |
CTRI/2025/12/098611 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Neurological Emergency Utility and Resource Optimization in Triage |
|
Scientific Title of Study
|
Health Technology Assessment (HTA) of point-of-care Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1(UCH-L1) biomarkers screening for optimizing triage of Traumatic Brain and Spinal Cord Injuries: A Cost-Effectiveness Study in Tertiary Care |
| Trial Acronym |
NEURO-TRIAGE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| R.12013/12/2025-HR |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RENU TOMAR |
| Designation |
Women Scientist |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
Department of Neurosurgery, GSVM Medical College, Kanpur-208002, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7317725311 |
| Fax |
|
| Email |
renutomar345@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manish Singh |
| Designation |
Head |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
Department of Neurosurgery, GSVM Medical College, Kanpur-208002, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9450996994 |
| Fax |
|
| Email |
manishsinghneurosurgry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manish Singh |
| Designation |
Head |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
Department of Neurosurgery, GSVM Medical College, Kanpur-208002, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9450996994 |
| Fax |
|
| Email |
manishsinghneurosurgry@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research
2nd Floor, IRCS Building,
1, Red Cross Road, New Delhi - 110001 |
|
|
Primary Sponsor
|
| Name |
Department of Health Research Ministry of Health and Family Welfare New Delhi |
| Address |
Department of Health Research
2nd Floor, IRCS Building,
1, Red Cross Road, New Delhi - 110001.
|
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Renu Tomar |
GSVM Medical College |
Department of Neurosurgery GSVM Medical College Kanpur
Kanpur Nagar
UTTAR PRADESH |
7317725311
renutomar345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical College Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S098||Other specified injuries of head, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Imaging based CT and MRI triage |
The triage and outcomes will be assessed based on CT and MRI scans |
| Intervention |
Point of care based Triage |
The biomarkers will be assessed through point of care machine and the triage will be done based on their results |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged more than 18 years
Patients presenting to the emergency department within 6 hours of suspected TBI or SCI
Patients with Glasgow Coma Scale (GCS) score between 9 to 15 (mild to moderate TBI) or suspected acute SCI based on clinical presentation.
Willingness to undergo rapid point-of-care GFAP and UCH-L1 screening.
Informed written consent provided by the patient or legal guardian. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| sensitivity, specificity, AUC |
Time points is specific time at which the outcome will be assessed estimated at baseline, 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="880"
Sample Size from India="440"
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)
|
31/01/2026 |
| 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) |
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
|
Traumatic Brain Injury and Spinal Cord Injury are major public health concerns that require rapid and accurate triage to reduce morbidity, mortality, and healthcare costs. Conventional diagnosis depends on computed tomography and magnetic resonance imaging, which increase resource use and radiation exposure in tertiary care. Point-of-care testing for Glial Fibrillary Acidic Protein and Ubiquitin C-terminal Hydrolase L1 has emerged as a promising biomarker-based tool for early identification of neurotrauma. This prospective, comparative, cohort study will evaluate the diagnostic accuracy and cost-effectiveness of point-of-care GFAP and UCHL1 testing compared with standard imaging-based triage among adults presenting within six hours of suspected traumatic brain or spinal cord injury. The study will measure diagnostic performance parameters such as sensitivity, specificity, positive and negative predictive values, and area under the ROC curve using CT or MRI findings as the reference standard. Cost-effectiveness will be assessed through incremental cost per quality-adjusted life year gained, together with reduction in imaging use, time to diagnosis, and hospital stay. Patient-centred outcomes including readmission rates and satisfaction will be recorded up to thirty days. The expected outcome is to establish evidence that biomarker-guided triage can safely and economically reduce unnecessary imaging, support faster decision making, and provide policy-relevant data for large-scale adoption of health technology assessment frameworks in emergency neurotrauma care. |