Clinical trial NCT04001348: Characteristics of Different Types of Safety Lancets on Blood Volume and Perceived Pain in Male and Female Volunteers
Official title: A Single-blind, Randomized, Uni-centre Study to Determine the Characteristics of Different Types of Safety Lancets on Blood Volume and Perceived Pain in Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: safety lancets
lancet
capillary blood
capillary blood sampling
blood volume
pain
Lead sponsor: HTL-Strefa S.A.
Sponsor class: INDUSTRY
First posted: 2019-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study was a randomized, single blind, uni-center pivotal study in male and female healthy volunteers, to determine capillary blood volume and pain perception obtained in a process of puncturing with different safety lancets.

A group of one hundred (100) healthy Caucasian male and female Subjects (aged \> 18 to \< 65 years old was randomized ) who were in good physical and mental condition. The Subjects had 4 (four) fingers (two fingers from each hand) lanced each with a different type of safety lancet. Overall, 4 (four) different safety lancets were investigated per each Subject.

Overall, 16 (sixteen) different safety lancets (4 different safety lancets per one Subject) were investigated, the capillary blood volume and pain were measured.


Eligibility criteria: Inclusion Criteria:

* Willing to sign the informed consent.
* Male and female volunteers.
* Age between 18 and 65 inclusive.
* Able to communicate well with the Investigator and comply with the requirements of the study.
* Volunteers who are in good physical and mental health.

Exclusion Criteria:

* Pregnancy or breastfeeding (self-reported).
* Confirmed or suspected malignant cancer History of poor blood circulation.
* Any skin condition on his or her fingers that prevents blood sampling.
* Anxiety with needles or finger pricks.
* Clotting disorders (including bleeding) in medical history.
* Neuropathy or other condition affecting sensation in the hands.
* History of blood borne infection (e.g., HIV, hepatitis B or C, syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T lymphotropic virus Type 1, Creutzfeldt-Jakob disease).
* Currently participating in another study.
* History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse.
* Intake of alcohol within 48 hours prior to the start of the study (self-reporting).
* Donation or loss of 400 mL or more of blood within 4 weeks prior to the start of the study.
* Any other condition that in the Investigator opinion may negatively influence Subject's participation in the study.
* Intake of medicines that affect blood coagulability (including anticoagulants such as vitamin K, antivirals and anticoagulants such as heparin, aspirin, thrombin inhibitors, vitamin K antagonists).

Primary outcomes:
measure: Volume (microliters) of blood in the capillary tube
timeFrame: The blood from the puncture site was collected to the capillaries by pressing during 2 minutes
Secondary outcomes:
measure: Pain perception: VAS
timeFrame: 5 minutes after lancing
Other outcomes:
Locations:
city: Cracovia
country: Poland
facility: Monipol Clinical Pharmacology Research Centre
state: Malopolskie
Study officials:
References:
citation: Serafin A, Malinowski M, Prazmowska-Wilanowska A. Blood volume and pain perception during finger prick capillary blood sampling: are all safety lancets equal? Postgrad Med. 2020 Apr;132(3):288-295. doi: 10.1080/00325481.2020.1717160. Epub 2020 Feb 6.