| CTRI Number |
CTRI/2025/09/095084 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Using Brain Scans to Check Blood Hemoglobin Levels. |
|
Scientific Title of Study
|
Objective Evaluation of Cerebral Venous Sinus Attenuation on NCCT Brain and its Correlation with Haematological Parameters in Anemic Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPriyanka Sanil |
| Designation |
Junior Resident 1 |
| Affiliation |
Datta Megha Institute of Higher Education and Research |
| Address |
Department of Radiodiagnosis,Ground floor,AVBRH Building,Sawangi,Meghe.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9920320424 |
| Fax |
|
| Email |
priyankasanil@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Mishra |
| Designation |
Professor |
| Affiliation |
Datta Megha Institute of Higher Education and Research |
| Address |
Department of Radiodiagnosis,Ground floor,AVBRH Building,Sawangi,Meghe.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9109053055 |
| Fax |
|
| Email |
drgvmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Mishra |
| Designation |
Professor |
| Affiliation |
Datta Megha Institute of Higher Education and Research |
| Address |
Department of Radiodiagnosis,Ground floor,AVBRH Building,Sawangi,Meghe.
MAHARASHTRA
442001
India |
| Phone |
9109053055 |
| Fax |
|
| Email |
drgvmishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research,Sawangi,Meghe,Wardha,India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi,Meghe,Wardha,India 442001 |
| 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 |
| DrPriyanka Sanil |
Acharya Vinoba Bhave Rural Hospital |
Department of Radiodiagnosis,Ground floor,AVBRH building,Sawangi,Megha.
Wardha
MAHARASHTRA |
9920320424
priyankasanil@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee,Datta Megha Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed with anemia based on WHO criteria hemoglobin less than 13 gms per dal for males, less than 12 gms per dal for females.
2. Underwent NCCT brain within 24 hours of complete blood count |
|
| ExclusionCriteria |
| Details |
1.Presence of intracranial hemorrhage, intracranial surgery, polytrauma, mass lesion, or significant artifact on CT affecting sinus evaluation.
2. History of recent blood transfusion within the past 72 hours.
3. Pregnant patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A significant correlation between attenuation values on NCCT brain and laboratory hemoglobin and hematocrit levels |
Assessment will be done at 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
01/10/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Non-contrast computed tomography NCCT of the brain is a rapid, widely available imaging tool that can provide indirect information about blood composition through cerebral venous sinus attenuation. Hemoglobin and hematocrit levels directly influence attenuation values, with anemia leading to physiologically reduced density that may mimic pathology, potentially resulting in diagnostic errors. This prospective observational cross-sectional study aims to objectively measure Hounsfield Unit values of major cerebral venous sinuses such as the superior sagittal and transverse sinuses in adult anemic patients and correlate these findings with hematological parameters obtained within 24 hours of imaging. By establishing reference attenuation ranges specific to anemia, the study seeks to improve the accuracy of NCCT interpretation, reduce false-positive diagnoses, and enhance decision making in emergency and resource-limited settings.
|