PT/INR Reference Interval IN Healthy Volunteers

Completed

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02319109

Run by

Microvisk Technologies Ltd

People needed

154

Starts

2014-12-01

Expected to finish

2015-01-01

Last updated by the study team

2015-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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