Clinical trial NCT03752229: Capillary Blood Volume and Pain Perception Obtained in a Process of Puncturing With Different Safety Lancets
Official title: A Randomized, Single Blind, Uni-centre Study in Healthy Volunteers, to Determine Capillary Blood Volume and Pain Perception Obtained in a Process of Puncturing With Different Safety Lancets
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: 2018-11-23
Enrollment: 300
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 three hundred (300) Caucasian male and female Subjects was randomized (aged \> 18 to \< 65 years old) 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, 48 (forty eight) 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:

* Confirmed or suspected malignant cancer
* Pregnancy or breastfeeding (only for women with childbearing potential based on pregnancy test conducted at Site)
* 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 volume was noted after 20 seconds
measure: Volume (microliters) of blood in the capillary tube
timeFrame: The blood volume was noted until the end of bleeding or up to 2 minutes time
Secondary outcomes:
measure: Pain perception
timeFrame: directly after lancing
measure: Pain perception
timeFrame: after 30 minutes ± 5 min after lancing
Other outcomes:
Locations:
city: Nadarzyn
country: Poland
facility: BioResearch Group Sp. z o.o.
state: Mazowieckie
Study officials:
References: