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

NCT ID: NCT01349712

Last Updated: 2011-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Blood Coagulation Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Coumadin (warfarin)

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universal Biosensors Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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College of Pharmacy Harding University

Principal Investigators

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Richard Ward, Pharm D

Role: PRINCIPAL_INVESTIGATOR

Harding University

Locations

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White River Diagnostic Clinic

Batesville, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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MOB 0158

Identifier Type: -

Identifier Source: org_study_id

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