Skip to main content
OpenTrials
Completed

NCT Number: NCT02319109

PT/INR Reference Interval IN Healthy Volunteers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diablo Research Clinic

Walnut Creek, California, 94598, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is considered a healthy volunteer
  • Subject is male or female, over 18 years of age
  • 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
  • Subject agrees to have blood drawn (venipuncture) and finger stick

Exclusion criteria

  • Subject is unable to give informed consent
  • Subject is less than 18 years of age
  • Female subject is pregnant
  • 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
  • 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)
  • Subject has already taken part in the study

Treatment and study plan

Primary outcomes

  1. INR value for normal population

    Time frame: 1 day

    Establish the INR value for the normal population

Secondary outcomes

  1. Safety (Number of Participants with Adverse Events)

    Time frame: 1 day

    Number of Participants with Adverse Events as a Measure of Safety

  2. Device Failure (number of device failures)

    Time frame: up to 12 weeks

    Overall number of device failures to measure the robustness of system

Sponsors and collaborators

Lead sponsor

Microvisk Technologies Ltd

Industry

Registry information

Official study title

A Prospective, Single-Center Study, in Healthy Volunteers to Establish a PT/INR Reference Interval for the Microvisk INR Test System

Acronym: REF01

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Dec 18, 2014
Registry last updated
Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.