Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood

This study has been completed.
Sponsor:
Information provided by:
Universal Biosensors Pty Ltd
ClinicalTrials.gov Identifier:
NCT01375725
First received: June 15, 2011
Last updated: June 16, 2011
Last verified: June 2011

June 15, 2011
June 16, 2011
September 2010
September 2010   (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: Five 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 NCT01375725 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood
Mobius PT-INR Accuracy Clinical Study

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects currently receiving coumadin (warfarin) treatment

Clotting Disorders
Not Provided
Coumadin (warfarin)
Subjects 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.
 
Completed
60
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01375725
MOB 0046
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
June 2011

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