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

Correlation of Feasibility Batches Using Warfarinised Blood

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01349712

Enrollment

200

Registered

2011-05-09

Start date

2011-05-31

Completion date

2011-11-30

Last updated

2011-05-09

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

Conditions

Blood Coagulation Disorders

Brief summary

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.

Detailed 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.

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

* 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

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	Fives 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