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临床试验/CTRI/2025/03/081632
CTRI/2025/03/081632尚未招募2 期

Hemoglide- Advanced blood smear and transport technology: A point of care haematology tool

Lalithaa J1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2025年3月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
3,000
试验地点
1
主要终点
To evaluate the effectiveness of Hemoglide, an advanced blood smear and transport technology, in improving the quality and efficiency of peripheral blood smear preparation

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • Hemolyzed samples.
  • Clotted samples.
  • Samples with insufficient volume.
  • Samples collected in incorrect anticoagulant.

结局指标

主要结局

To evaluate the effectiveness of Hemoglide, an advanced blood smear and transport technology, in improving the quality and efficiency of peripheral blood smear preparation

时间窗: Immediately after smear preparation and staining (within 1 hour of sample collection).

次要结局

  • 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.)
  • 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))

研究者

发起方
Lalithaa J
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Lalithaa J

Saveetha Medical College and Hospital

研究点 (1)

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