Study to Test the Accuracy of a Prototype Handheld PT/INR Device

Universal Biosensors

Status: Unknown

Conditions: Blood Coagulation Disorders

Study type: Observational

Funder types: Industry

Identifiers

NCT01349712

MOB 0158

Details and patient eligibility

About

The purpose of this study is to measure prothrombin time (PT) on an experimental device and a commercially available device on persons receiving coumadin (warfarin)treatment.

Full description

This study will require participants to have up to 2 finger-punctures taken and sample tested on a strip and meter system for both the experimental and commercially available devices.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently taking coumadin (warfarin)
• Aged 18 years or older
• Able and willing to provide informed consent
• Can understand (read and write) English

Exclusion criteria

• None

Trial design

200 participants in 1 patient group

Coumadin (warfarin)

Description:

Subjects are required to be currently receiving coumadin (warfarin) treatment.