Application Format For Submission Of Research Proposal/ Project For Approval Of

The Local Research Advisory Committee (LRAC) Of The Medical College/Institute

Under The Multi-Disciplinary Research Unit (MRU)

1. Name Of The Medical

College/Institute Of The
Multidisciplinary Research Unit ANDHRA MEDICAL COLLEGE
(MRU) VISAKHAPATNAM

Comparative Analysis of Diagnostic and Prognostic

Biomarkers for Different Severity of Traumatic
2. Project Title
Brain Injury and Their Relationship with Brain CT
Findings

3. Specific Area of the proposed Department of Emergency Medicine

research

1. To compare the levels of diagnostic and prognostic

biomarkers in patients with different severity
4. Objective of the Study
of TBI.

2. To investigate the relationship between biomarker

levels and brain CT findings in patients with TBI

3. To evaluate the prognostic value of biomarkers in

predicting the outcome of TBI.

1.To find that the diagnostic and prognostic accuracy of

5. Aims and significance of the
project
biomarkers for TBI varies depending on the severity of
TBI.
2.To prove that there will be a significant association
between biomarker levels and brain CT findings.
 3.To identify a panel of biomarkers that can improve the
diagnosis and prognosis of TBI and reduce the need for
repeated CT scans.

Study Design:

6. Plan of work, methods and We can use a sample size calculator for ANOVA to
techniques to be used calculate the required sample

Size per group: Based on the calculator, the required

sample size per group is 56.

However, to account for Potential dropouts or missing

data, we will increase the sample size by 10%, resulting
in a total sample Size of approximately 247 (62
participants per group).

Sample Selection:

This will be a prospective observational study that will

enroll patients with TBI from the Emergency department
of a tertiary care hospital. After approval from the Ethics
Committee and informed consent, Size of approximately
247 (62 participants per group) fulfilling the eligibility
criteria and giving informed consent will be taken for the
study.

Place Of Work:

AMC/KGH. Department of Emergency Medicine

Inclusion criteria :
.

Exclusion criteria :

Methodology:

l. Patients will be classified into mild, moderate, or severe

TBI based on the Glasgow Coma Scale (GCS) score.

Blood samples will be collected from patients at

Admission and at 24 hours after admission. The

biomarkers that will be measured include S100B,neuron
specific enolase (NSE), glial fibrillary acidic protein
(GFAP), and ubiquitin C-terminal hydrolase L1 (UCH-
L1)

Using commercially available ELISA kits. The levels of

the biomarkers will be compared between the

Patients with different levels of severity in TBI and the

control group. Brain CT scans will be performed at

Admission and at 24 hours after admission. The CT scans

will be evaluated for the presence of intracranial

Hemorrhage, brain edema, and midline shift.

Results & Data analysis:

The primary outcome measures will be the diagnostic

Accuracy of each biomarker for TBI and their ability to

predict long-term outcomes.
 The secondary outcome measures will be the correlation
between biomarker levels and brain CT findings.

Study Period :

7. Time-table or milestones

8. Deliverables

9. Principal Investigator (PI):

a. Title: Prof/Dr/Mr./Ms- Professor

b. Name

Andhra Medical College

c. Full official address Visakhapatnam 530 002

 Mobile/Telephone

Fax

Email

d. Position

e. Date of Birth

f. Highest Degree University/ Institute

Date

g. Total time to be devoted to project (in man

months per year)

10. Other participants (give name, address, and highest qualification for each of the
CO-Principal-Investigator) (CO-I):

NAME

ADDRESS

11. Names and addresses of other research scientists actively engaged in the general
area of the proposed research:

12. List not more than 10 of your publications with full bibliographic
details/reports/patents or other documents in the last 5 years:

Publications List Enclosed

13. Proposal budget (to be utilized from within the MRU budget):
14. Utilization of Available institutional facilities :

15. Research support availed/being availed/applied for by the PI from different sources,
like Department of Health Research (Grant-aid-Scheme), ICMR (extra mural), CSIR,
DST/DBT, etc:

Grant agency Title of the project Duration (from Amount in lakh Rs.
and reference number mm/yy to mm/yy)

16. Declaration and attestation:

We certify that all the details declared here

are correct and complete.

1. Signature of PI
Date:

2. Signature of CO-is

a)
Date:

17. Certificate of the heads of the department and institution:

We have read the terms and conditions of MRU scheme. The necessary institutional facilities
are available and will be provided for the implementation of this research proposal. Full
account of expenditure will be rendered by the institution yearly.
Name of the head: Name of the Nodal Officer:

of the institution/medical college of the MRU

Signature with date: Signature with date:

Seal: Seal:

18. Recommendations of the Research Signature of the Chairman of RAC:

Advisory Committee:

___________________________

19. Recommendations/Suggestions of the Signature of the Chairman of NAC:

National Level Advisory Committee:

___________________________