Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood

NCT ID: NCT01375725

Last Updated: 2011-06-17

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

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Clotting 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 currently receiving coumadin (warfarin) treatment.

No interventions assigned to this group

Eligibility Criteria

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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
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 0046

Identifier Type: -

Identifier Source: org_study_id

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