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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Universal Biosensors Pty Ltd
ClinicalTrials.gov Identifier:
NCT01349712
First received: April 29, 2011
Last updated: May 5, 2011
Last verified: May 2011

April 29, 2011
May 5, 2011
May 2011
November 2011   (final data collection date for primary outcome measure)
PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device [ Time Frame: Fives days to collect data and up to two weeks to generate correlation graph ] [ Designated as safety issue: No ]
To determine the correlation of PT/INR values between an experimental and commercial device.
Same as current
Complete list of historical versions of study NCT01349712 on ClinicalTrials.gov Archive Site
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Study to Test the Accuracy of a Prototype Handheld PT/INR Device
Correlation of Feasibility Batches Using Warfarinised Blood

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Subjects currently receving coumadin(warfarin) treatment

Blood Coagulation Disorders
Not Provided
Coumadin (warfarin)
Subjects are required to be currently receiving coumadin (warfarin) treatment.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01349712
MOB 0158
No
Richard Ward, Assistant Professor, College of Pharmacy Harding University
Universal Biosensors Pty Ltd
Not Provided
Principal Investigator: Richard Ward, Pharm D Harding University
Universal Biosensors Pty Ltd
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP