PT/INR Reference Interval IN Healthy Volunteers (REF01)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy

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.

• Study Type: Observational
• Enrollment (Actual): 154

Contacts and Locations

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Diablo Research Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
INR value for normal population	Establish the INR value for the normal population	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (Number of Participants with Adverse Events)	Number of Participants with Adverse Events as a Measure of Safety	1 day
Device Failure (number of device failures)	Overall number of device failures to measure the robustness of system	up to 12 weeks

Collaborators and Investigators

• Sponsor: Microvisk Technologies Ltd
• Investigators: Principal Investigator: Helen Stacey, MD, PhD, Diablo Clinical Research

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: December 17, 2014
• First Posted (Estimate): December 18, 2014

Study Record Updates

• Last Update Posted (Estimate): January 22, 2015
• Last Update Submitted That Met QC Criteria: January 21, 2015
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 2011/REF01