NCT02319109

PT/INR Reference Interval IN Healthy Volunteers

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 154 (actual)
• Sponsor: Microvisk Technologies Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Timeline

• Start date: 2014-12-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2014-12-18
• Last updated: 2015-01-22

Locations

1 site across 1 country: United States