Clinical trial NCT02319109: PT/INR Reference Interval IN Healthy Volunteers
Official title: A Prospective, Single-Center Study, in Healthy Volunteers to Establish a PT/INR Reference Interval for the Microvisk INR Test System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Microvisk Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2014-12-18
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy male and female subjects, not taking any oral vitamin K antagonist therapy, over the age of 18 years.

Brief summary: This is a prospective, single-center study in healthy volunteers to establish a PT/INR reference interval for the Microvisk International Normalized Ratio (INR) Test System. The primary objective of this study is to establish the reference interval for the measurement of prothrombin time (PT/INR) using the Microvisk INR Test System. The second objective is to evaluate the safety of the device.

Detailed description: Healthy volunteers who meet eligibility criteria, have been fully informed and provided written informed consent will be enrolled into this study. Each participant will be required to donate up to 3 finger stick samples for testing on one occasion. The maximum trial duration for each participant is one visit/occasion. This will be followed by a standard venipuncture for (1) a neutral tube (Red Top) for analysis by the on-test method, (1) one sodium citrate tube (Blue Top) for analysis by the comparative/reference laboratory method. Sample collection will take place within the clinic session. The maximum trial duration for each participant is one clinic session.

Eligibility criteria: Inclusion Criteria:

1. Subject is considered a healthy volunteer
2. Subject is male or female, over 18 years of age
3. Subject is informed and has been given ample time and opportunity to think about his/her participation and has given his/her written informed consent
4. Subject agrees to have blood drawn (venipuncture) and finger stick

Exclusion Criteria:

1. Subject is unable to give informed consent
2. Subject is less than 18 years of age
3. Female subject is pregnant
4. Subject is on anticoagulant medication or other medication known to affect PT/INR assessment (e.g., warfarin, heparin) for a minimum of 28 days before enrolling in the trial
5. Subject has a medical condition known to affect PT/INR (e.g. vitamin K deficiency, disseminated intravascular coagulation, liver disease, decreased or defective factor I, II, V, VII, or X)
6. Subject has already taken part in the study

Primary outcomes:
measure: INR value for normal population
timeFrame: 1 day
Secondary outcomes:
measure: Safety (Number of Participants with Adverse Events)
timeFrame: 1 day
measure: Device Failure (number of device failures)
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Diablo Research Clinic
state: California
Study officials:
affiliation: Diablo Clinical Research
name: Helen Stacey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: