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CTRI Number  CTRI/2025/03/081632 [Registered on: 04/03/2025] Trial Registered Prospectively
Last Modified On: 28/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of blood smear technique using Hemoglide tool with conventional method 
Scientific Title of Study   Hemoglide- Advanced blood smear and transport technology: A point of care haematology tool  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lalithaa J 
Designation  Postgraduate in Pathology 
Affiliation  Saveetha Medical College and Hospital 
Address  Dept. of Pathology, Saveetha medical college and hospital, Thandalam

Chennai
TAMIL NADU
602105
India 
Phone  9600638760  
Fax    
Email  jayapallalithaa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sudha V 
Designation  Associate Professor 
Affiliation  Saveetha Medical College and Hospital 
Address  Dept. of Pathology, Saveetha medical college and hospital, Thandalam

Chennai
TAMIL NADU
602105
India 
Phone  9361209102  
Fax    
Email  rpsmcchni@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Lalithaa J 
Designation  Postgraduate in Pathology 
Affiliation  Saveetha Medical College and Hospital 
Address  Dept. of Pathology, Saveetha medical college and hospital, Thandalam


TAMIL NADU
602105
India 
Phone  9600638760  
Fax    
Email  jayapallalithaa@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, NH 48, Chennai, Tamil Nadu - 602105, India 
 
Primary Sponsor  
Name  Lalithaa J 
Address  Dept. of Pathology, Saveetha medical college and hospital, Thandalam, Chennai- 602105, India 
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 Lalithaa J  Saveetha medical college and hospital  Room no. 503, Department of Pathology,Central laboratory, Hospital block
Chennai
TAMIL NADU 
9600638760

jayapallalithaa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R718||Other abnormality of red blood cells,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional slide:  1.Prepare a blood smear manually using a spreader slide. 2.Follow traditional methods for slide preparation as a control. 
Comparator Agent  Hemoglide slide:  1.Place a slide onto the lower unit of the Hemoglide device. 2.Apply a blood sample onto the slide using a pipette. 3.Attach the spreader blade to the upper unit and position it to smear the sample across the slide. 4.Activate the device’s smear preparation mechanism. 5.Use the control system to regulate speed and ensure uniform smear preparation. 
Intervention  Staining and analysis  1)Stain both the Hemoglide-prepared and manually prepared slides using standard staining protocols. 2)Analyze the stained slides under a microscope to assess: a)Quality of Smear: Evaluated based on uniformity of cell distribution, even spreading, and absence of artifacts such as clumping or streaks. b)Staining Quality: Determined by the clarity of stained components, absence of overstaining or understaining, and consistency across the smear. c)Cell Morphology Clarity: Assessed by the ease of identifying and differentiating cellular components such as red blood cells, white blood cells, and platelets. d)Smear Preparation Time: Measured as the time taken (in seconds) to prepare and stain a slide, recorded from the moment the sample is applied until it is ready for analysis. 3)Record the diagnostic turnaround time for each method: a)Measure the time taken from sample collection to final diagnostic reporting for both Hemoglide and conventional methods (in minutes). b)Record and compare the turnaround times to evaluate efficiency improvements offered by Hemoglide. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  - Whole blood samples collected in EDTA anticoagulant tubes.

- Samples from patients across all age groups and genders with clinical indications such as anemia, infection, leukemia, or other haematological conditions. 
 
ExclusionCriteria 
Details  - Hemolyzed samples
- Clotted samples
- Samples with insufficient volume
- Samples collected in incorrect anticoagulant 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of Hemoglide, an advanced blood smear and transport technology, in improving the quality and efficiency of peripheral blood smear preparation  Immediately after smear preparation and staining (within 1 hour of sample collection). 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the accuracy of peripheral blood smear preparation between Hemoglide & conventional slide prepation  After smear preparation & staining (within 1 hour), & after review by a blinded pathologist (within 24 hours) 
To compare the parameters like quality of smear (uniformity, distribution, absence of artifacts), staining quality, cell morphology clarity & smear preparation time.  Smear preparation time: Measured at the time of smear preparation.

Smear quality parameters: Evaluated immediately after staining & drying (within 1 hour).

Blinded assessment by pathologists: Within 24 hours. 
To compare the diagnostic turnaround time between Hemoglide & conventional slide prepation  From the time of blood sample collection to the final pathologist report, recorded for each method (Hemoglide vs. conventional) 
 
Target Sample Size   Total Sample Size="3000"
Sample Size from India="3000" 
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   Phase 2 
Date of First Enrollment (India)   20/03/2025 
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="1"
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   Peripheral blood smears are a fundamental diagnostic tool in haematology, essential for detecting and monitoring various blood disorders. However, traditional smear preparation methods are labour-intensive, time-consuming, and prone to human error, leading to variability in smear quality and diagnostic accuracy. As the demand for reliable and efficient diagnostic processes increases, technological advancements are needed to streamline laboratory workflows and enhance the consistency of smear preparations. Improving diagnostic accuracy is crucial because consistent and high-quality blood smears are essential for accurate haematological analysis. Current manual methods often produce variable smear quality, compromising diagnostic precision and patient outcomes.
By developing a semi-automated device, we can ensure more uniform sample distribution, enhancing the reliability of diagnostic results. Enhancing laboratory efficiency is another significant need addressed by this research. Manual smear preparation is repetitive and timeconsuming, occupying valuable time for laboratory personnel. A semi-automated solution can reduce the time and labor required for smear preparation, allowing staff to focus on more complex tasks and improving overall laboratory productivity. Reducing human error is critical, as the manual nature of traditional smear preparation increases the risk of errors, such as uneven sample distribution and contamination. Automation can minimize these errors, ensuring more reliable and reproducible results, thereby improving the quality of diagnostics. Facilitating access to advanced diagnostics is also a key consideration. Simplifying the smear preparation process with a semi-automated device can make advanced diagnostic capabilities more accessible, particularly in resource-limited settings where skilled laboratory technicians may be scarce. This can lead to better healthcare outcomes in underserved areas.
Supporting research and innovation is essential for the continuous improvement of diagnostic methods. Developing advanced tools like this can drive further innovation in laboratory technologies, encouraging ongoing advancements in medical science and enhancing overall diagnostic practices.
This device aims to address these needs by providing a semi-automated solution that enhances the efficiency, accuracy, and reproducibility of peripheral blood smear preparations. This innovation promises to improve diagnostic outcomes and laboratory operations, benefiting both healthcare providers and patients.
Hemoglide design: The device comprises a lower unit with designated locations for disposable slides, and an upper unit that is movably connectable to the lower unit. The upper unit accommodates a spreader blade for smearing samples onto slides. Notably, the upper unit features side parts that substantially cover the sides of the lower unit, improving handling and reducing the risk of sample contamination. Additionally, the device incorporates a system for controlling the speed at which the upper and lower units move with respect to each other, ensuring precise smear preparation.
Collect peripheral blood samples from participants using standard venipuncture techniques. Label and document each sample accurately to ensure traceability.
Slide Preparation Using Hemoglide:
• Place a slide onto the lower unit of the Hemoglide device at the designated receiving location.
• Apply the blood sample onto the slide using a pipette.
• Attach the spreader blade to the upper unit and position it to smear the sample across the slide.
• Activate the smear preparation mechanism to evenly distribute the blood sample.
• Use the device’s control system to regulate the speed and ensure uniform smear preparation.
Slide Preparation Using Conventional Method:
• Prepare a peripheral blood smear using traditional manual methods as a control.
• Apply the blood sample onto a slide and use a spreader slide to create a smear manually
Staining and Analysis:
• Stain both the Hemoglide-prepared and manually prepared slides using standard staining protocols.
• Analyze the stained slides under a microscope to assess the quality of smear preparation.
• The parameters include Quality of Smear (Uniformity, Distribution, Absence of Artifacts), Staining Quality, Cell Morphology Clarity, Smear Preparation Time and Turnaround Time 
 
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