| CTRI Number |
CTRI/2025/09/094924 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Automated Blood Tests and Traditional Blood Smear Examination in Anemia Patients. |
|
Scientific Title of Study
|
Correlation between Automated CBC Analysis and Conventional
Peripheral Blood Smear Assessment in anaemia 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 |
Dr Keshav |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pathology, Jawaharlal Nehru Medical College, DMIHER, Sawangi Meghe, Wardha.
Wardha
MAHARASHTRA
442107
India
Wardha MAHARASHTRA 442107 India |
| Phone |
7838179055 |
| Fax |
|
| Email |
keshavnsy@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Keshao Madhukarrao Hiwale |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pathology, Jawaharlal Nehru Medical College, DMIHER, Sawangi Meghe, Wardha.
Wardha
MAHARASHTRA
442107
India
Wardha MAHARASHTRA 442107 India |
| Phone |
9823749905 |
| Fax |
|
| Email |
keshaohiwale5@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Keshao Madhukarrao Hiwale |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pathology, Jawaharlal Nehru Medical College, DMIHER, Sawangi Meghe, Wardha.
Wardha
MAHARASHTRA
442107
India
Wardha MAHARASHTRA 442107 India |
| Phone |
9823749905 |
| Fax |
|
| Email |
keshaohiwale5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research (DMIHER), Sawangi Meghe, Wardha, Maharashtra442107
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research (DMIHER) |
| Address |
Datta Meghe Institute of Higher Education and Research (DMIHER), Sawangi Meghe, Wardha, Maharashtra- 442107 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Keshav |
Acharya Vinoba Bhave Rural Hospita |
Department of Pathology, AVBRH and Siddharth Gupta Memorial
Hospital, Datta Meghe Institute of Higher Education
and Research (DMIHER), Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA Wardha MAHARASHTRA |
7838179055
keshavnsy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research (Deemed to be University)Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients with anaemia defined as per WHO reference ranges :
1. Hb less than 13 gm/dl (men)
2. Hb less than 12gm/dl (women)
3. Hb less than 11gm/dl (pregnant women) |
|
| ExclusionCriteria |
| Details |
1. Clotted blood sample.
2. Cases in which no consensus will be reached between the observers on microscopy.
3. Artefactual changes in red cells obscuring and altering morphological features. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the correlation and comparison between automated CBC analysis (including RBC indices and histograms) and conventional peripheral blood smear assessment in the characterization and classification of anaemia. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="365" Sample Size from India="365"
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)
|
27/09/2025 |
| 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 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
|
Background Anaemia is a major global health problem, particularly prevalent in India, affecting both men and women and contributing to significant morbidity. Automated complete blood count (CBC) analyzers have improved accuracy and efficiency in anemia evaluation, providing red cell indices and histograms. However, conventional peripheral blood smear (PBS) examination remains indispensable for identifying morphological abnormalities, parasites, and subtle red cell changes that may be missed by automation. Hence, correlating automated CBC with PBS helps in validating and complementing diagnostic accuracy. Methodology This is an observational, analytical, prospective study conducted in Central Clinical Laboratory section of Pathology Department at Jawaharlal Nehru Medical College, Sawangi (Meghe) over two years. A total of 365 anaemia patients (as per WHO criteria) will be included. Blood samples will be processed using an automated hematology analyzer (Beckman Coulter DXH 800) to obtain hematological parameters and RBC histograms. Parallel peripheral blood smears will be prepared, stained with Leishman stain, and assessed by two independent observers blinded to CBC data. RBC morphology, WBCs, and platelets will be documented. The findings of automated CBC will be compared with PBS for categorization of anemia (microcytic, normocytic, macrocytic; normochromic/hypochromic). Conclusion The study aims to establish the correlation between automated CBC analysis and peripheral smear examination in anemia characterization. The outcome is expected to highlight the strengths and limitations of automation, reaffirming the continued relevance of PBS in identifying morphological abnormalities. The findings may help optimize diagnostic protocols by combining both methods for more accurate classification of anemia in clinical practice. |