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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  
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 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  
Status 
Not Applicable 
 
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.

 
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