PT/INR Reference Interval IN Healthy Volunteers

NCT02319109 | Completed

• 1 other identifier: 2011/REF01
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• INR value for normal population

  Establish the INR value for the normal population

  1 day

Secondary Outcomes (2)

• Safety (Number of Participants with Adverse Events)

  1 day

• Device Failure (number of device failures)

  up to 12 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Microvisk Technologies Ltd: lead

Study Sites (1)

Diablo Research Clinic

Walnut Creek, California, 94598, United States

Location

Study Officials

• Helen Stacey, MD, PhD

  Diablo Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 18, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: January 22, 2015

Record last verified: 2014-12

Locations

US (1)