| 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
|
|
|
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
|
|
|
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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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 |