FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/074663 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 21/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   neuron specific enolase as prognosis marker in traumatic brain injury 
Scientific Title of Study   Utility Of Neuron Specific Enolase in Traumatic Brain Injury in Assessing Severity and Outcome in Neuro-Critical Patients. An 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  SAURAV SHEKHAR 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anesthesia (Trauma & Emergency)

Patna
BIHAR
800014
India 
Phone  9308921568  
Fax    
Email  sauravshekhar99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SAURAV SHEKHAR 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anesthesia (Trauma & Emergency)


BIHAR
800014
India 
Phone  9308921568  
Fax    
Email  sauravshekhar99@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SAURAV SHEKHAR 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anesthesia (Trauma & Emergency)


BIHAR
800014
India 
Phone  9308921568  
Fax    
Email  sauravshekhar99@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Medical Sciences PATNA BIHAR 800014 
 
Primary Sponsor  
Name  DR SAURAV SHEKHAR 
Address  Associate Professor department of Anesthesia Trauma & Emergency 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saurav Shekhar  Indira Gandhi Institute of Medical Sciences  Department of Anesthesia (Trauma & Emergency)
Patna
BIHAR 
9308921568

sauravshekhar99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indira Gandhi Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S062||Diffuse traumatic brain injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Inclusion criteria
All stroke patients (ischaemic/haemorrhagic) will be included in this study
All patients of age group greater than 40 years and of both sexes

 
 
ExclusionCriteria 
Details  patients relatives refusal
any patients with sepsis
any patients with any neural tumours or any other cancer 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
correlation between NSE levels and injury severity, assessed by NIHSS score at icu admission  at time of admission to icu

at 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
relationship between functional outcome & NSE levels. We will also try to ascertain any cutoff value of the NSE level to predict mortality at 48 h after admission.  Baseline , 4 weeks  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/10/2024 
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="0"
Months="4"
Days="9" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
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  

Introduction:

Traumatic brain injury (Ischemic stroke) is a major global health issue, ranking as the second leading cause of death and the primary cause of adult disability worldwide. Given the broad range of possible outcomes for patients—which can vary from complete recovery to death—and the availability of various treatment options, identifying prognostic factors that can quickly and accurately predict clinical outcomes is crucial.

NSE protein is in the cytoplasm of neurons and plays a role in energy metabolism. As NSE has significant use in several neurological disorders, such as head injury, intracerebral haemorrhage, cardiac arrest, anoxic encephalopathy, encephalitis, and status epilepticus . Recent studies have investigated its relationship with ischemic stroke and its characteristics, such as infarcted brain volume, the severity of clinical manifestations, and short- and long-term prognosis. Despite these efforts, current research on the effectiveness of NSE as a blood biomarker for acute ischemic stroke has not provided conclusive results, and its impact on the outcomes of these patients remains poorly understood.

Neuron-specific enolase (NSE) is an essential protein most recognized for its enzymatic properties during the late stages of glycolysis. NSE has a myriad of other cellular functions and acts primarily on neuronal and neuroendocrine tissues. Under normal physiological conditions, NSE is not secreted into extracellular space, however, during cellular injury or death, NSE can be both leaked into the extracellular space and upregulated in response to the damaged neuronal tissue. NSE has been used as a biomarker in numerous pathological conditions in humans. For decades, NSE assessment has been notable for its usefulness in patients who have certain neuroendocrine malignancies or those who suffer from hypoxic brain damage due to cardiac arrest or ischemic stroke. Additionally, as scientists and clinicians work to risk stratify and guide prognosis in traumatic brain and spinal cord injuries, NSE assessment has shown promise as a biomarker. Though elevated serum levels of NSE in patients after mild traumatic brain injury (TBI) have been reported in multiple studies, the single use of NSE for risk stratification or outcome prognosis in mild TBI appears to have limitations. In severe TBI, higher NSE concentrations are associated with elevated intracranial pressure, severity of traumatic brain damage, adverse outcomes, and mortality. Albeit promising, there remains a lack of standardization with regards to timing of the blood sampling, cutoff ranges and assays when utilizing NSE as a biomarker for traumatic brain injury.

An ideal blood biomarker for stroke should provide reliable results, enable fast diagnosis, and be readily accessible for practical use. Neuron-specific enolase (NSE), an enzyme released after neuronal damage, has been studied as a marker for brain injury, including cerebral infarction

 

Aims & objective:

To assess neuron specific enolase as a biomarker to evaluate severity of brain damage and prediction of outcome in neurocritical patients with traumatic brain damage.

Material and methods:

After institutional ethical clearance, this observational study will include 100 patients with traumatic brain injury in this study. Patients presenting in our icu within 72hours of onset of symptoms will be included in our study. Neuron specific enolase will be done for such patients and will be repeated after 72 hours again.

Following parameters will be studied:

1)     correlation between NSE levels and injury severity, assessed by NIHSS score at icu admission

2)     affected brain volume versus NSE levels : In this method, the infarcts size is calculated as follows: the area (A × B) of the infarct size is measured at the plane with the largest infarct expansion; this area is then multiplied by the number of scan slices on which the infarct is visible multiplied by the slice thickness (C); the resulting volume is then divided by 2

3)     relationship between functional outcome and NSE levels. 30 days post-discharge outcome with the NSE levels. We will also try to ascertain any cutoff value of the NSE level to predict mortality at 48 h after admission.


 
Close