| CTRI Number |
CTRI/2023/03/050964 [Registered on: 22/03/2023] Trial Registered Prospectively |
| Last Modified On: |
20/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of novel technique to detect intracranial bleed after head injury |
|
Scientific Title of Study
|
Medical Diagnosis, Triage and Monitoring of Effect of RN Exposure and Associated Traumatic Injury |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maria M Dsouza |
| Designation |
Head of Division of Radiological, Nuclear and Imaging Sciences |
| Affiliation |
INMAS, DRDO |
| Address |
Division of Radiological, Nuclear and Imaging Sciences
INMAS
Ministry of Defence
Brig SK Majumdar Marg
New Delhi
DELHI
110054
India |
| Phone |
|
| Fax |
|
| Email |
mmathew.inmas@gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maria M Dsouza |
| Designation |
Head of Division of Radiological, Nuclear and Imaging Sciences |
| Affiliation |
INMAS, DRDO |
| Address |
Division of Radiological, Nuclear and Imaging Sciences
INMAS
Ministry of Defence
Brig SK Majumdar Marg
New Delhi
DELHI
110054
India |
| Phone |
|
| Fax |
|
| Email |
mmathew.inmas@gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maria M Dsouza |
| Designation |
Head of Division of Radiological, Nuclear and Imaging Sciences |
| Affiliation |
INMAS, DRDO |
| Address |
Division of Radiological, Nuclear and Imaging Sciences
INMAS
Ministry of Defence
Brig SK Majumdar Marg
New Delhi
DELHI
110054
India |
| Phone |
|
| Fax |
|
| Email |
mmathew.inmas@gov.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
INMAS - Defence Research and Development Organisation |
| Address |
Brig SK Mazumdar Marg, Timarpur, New Delhi, Delhi 110054 |
| Type of Sponsor |
Research institution |
|
|
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 Ajay Choudhary |
Dr Ram Manohar Lohia Hospital |
Department of Neurosurgery, Neurosurgery Division
New Delhi
DELHI |
9312458450
mmathew.inmas@gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ABVIMS, Dr. RML Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S068||Other specified intracranial injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participants with a suspected head injury and referred for a head CT scan |
|
| ExclusionCriteria |
| Details |
Major scalp laceration, active bleeding, significant extracranial hematoma or skull abnormality, or any other condition that would not allow device placement, participants with a history of brain
surgery or neurologic disease and pregnant women |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical Parameters Sensitivity, Specificity and Accuracy of the novel mNIRS (CEREBO) to detect traumatic intracranial hemorrhages in suspected head injury cases |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the design refinements for better usability for defence deployment |
3 years |
|
|
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)
|
01/04/2023 |
| 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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Traumatic Brain Injury (TBI) is a potentially fatal and debilitating condition that can cause long-term physical and cognitive impairments even if the patient survives. The prognosis deteriorates significantly with time, thus early detection and timely intervention is essential. Current clinical diagnostic tools are insufficient and there is an increasing need for a quick, accurate, and affordable computer-aided method that can collect the features of hematoma and provide early diagnosis. The novel mNIRS is a triaging tool that detects traumatic intracranial hemorrhage objectively. The present study evaluates its performance by clinically estimating its efficacy in detecting the intractranial hemorrhage in comparison to the head CT scans |