Characteristics of Different Types of Safety Lancets on Blood Volume and Perceived Pain in Male and Female Volunteers
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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Jun 2013
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 26, 2019
CompletedFirst Posted
Study publicly available on registry
June 28, 2019
CompletedJune 28, 2019
June 1, 2019
1 month
June 26, 2019
June 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Volume (microliters) of blood in the capillary tube
The amount of capillary blood volume collected after a single lancing of the fingertip.
The blood from the puncture site was collected to the capillaries by pressing during 2 minutes
Secondary Outcomes (1)
Pain perception: VAS
5 minutes after lancing
Study Arms (4)
HTL-STREFA S.A.safety lancet type 610
EXPERIMENTALHTL-STREFA S.A.safety lancet type 553-556
EXPERIMENTALHTL-STREFA S.A.safety lancet type 430
EXPERIMENTALHTL-STREFA S.A.safety lancet type 520
EXPERIMENTALInterventions
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HTL-Strefa S.A.lead
Study Sites (1)
Monipol Clinical Pharmacology Research Centre
Krakow, Lesser Poland Voivodeship, 30-969, Poland
Related Publications (1)
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.
PMID: 32027205DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2019
First Posted
June 28, 2019
Study Start
June 1, 2013
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
June 28, 2019
Record last verified: 2019-06