Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood

Mobius PT-INR Accuracy Clinical Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01375725

Enrollment

Registered

2011-06-17

Start date

2010-09-30

Completion date

2010-09-30

Last updated

2011-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clotting Disorders

Brief summary

The purpose of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an experimental device and a commercially available device. This study will involve taking a finger-puncture and testing onto a strip and meter system for the experimental and commercially available devices.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Are currently taking coumadin (warfarin) * Are aged 18 years or older * Able and willing to provide informed consent * Can understand (read and write) English * Required to provide a capillary sample as part of their routine medical check

Exclusion criteria

* Previously participated in this study

Design outcomes

Primary

Measure	Time frame	Description
PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device	Five days to collect data and up to two weeks to generate correlation graph	To determine the correlation of PT/INR values between an experimental and commercial device

Countries

United States

Outcome results