Evaluation of blood volume, test values, and pain for automatic blood collection device from fingers using single-use automatic lancet (medical equipment)

JRCT ID: jRCTs042200104

Registered date:03/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Volunteers
• Date of first enrollment: 03/03/2021
• Target sample size: 200
• Study type: Interventional
• Intervention(s): Blood sample collection; Capillary blood sampling by finger-prick ( 2 times) , upper arm (elbow) Vein Blood collection (1 time)

Outcome(s)

Primary Outcome

1) Blood collection volume
For all cases, blood collection volumes with the prototype device should be recorded as follows, considering target volume and time. The target volume and time is 250 uL in 90 seconds for complete blood count tests, and 400 uL in 150 seconds for biochemistry and immunoassay tests.
- Complete blood count;
Time at 250uL collected (time less than 90 seconds),
Volume at 90 seconds (volume less than 250uL)
- Biochemistry and Immunoassay;
Time at 400uL collected (time less than 150 seconds),
Volume at 150 seconds (volume less than 400uL)

In addition, using fiber cameras built into the prototype device, changes of blood volume in a micro blood collection tube and changes of bleeding from the fingertip are recorded in the video. This video is used to evaluate the time variation of the bleeding speed.

2) Measured values of the test items
The same test items of the fingertip blood and of the venous blood are measured with the same instruments and the same reagents.
The results are to be evaluated in variation, correlation, and deviation points of view.

3) Pain
The research subjects assess the pain of the fingertip blood collection in 0-10 degrees by questionnaire. The degree of pain is compared with that of the upper arm (elbow) vein puncture.

Secondary Outcome

4)Relationships between the blood volumes collected from fingertips and the fingertip vascular images
- Relationships between the collected blood volumes and the prick positions in the fingertip vascular images
- Common characteristics in the fingertip vascular images of the research subjects who can collect larger (or smaller) blood volumes from fingertips

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 70age old
• Gender: Both

Include criteria

1. Persons who apply for this study, after receiving a sufficient explanation of the study, provide the consent of the document based on their own free will.
2. Those selected by the research director or research contributor in consideration of reducing bias in the age group and gender.

Exclude criteria

1. Person who did not provide a document consent based on free will of the person
2. Person deemed inappropriate by the research director

Related Information

• Primary Sponsor: Hiroyasu Ito
• Secondary Sponsor: Irie Takashi,Hitachi High-Tech Corporation