Study to Determine the Accuracy of Prothrombin Time of Warfarinised blood.

In patients taking warfarin, how do the Prothrombin(PT)/International Normalised Ratio (INR) results from Universal Biosensors, CoaguChek point-of-care INR devices correlate to a standard laboratory laboratory method.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000701022

Acronym

N/A

Enrollment

Registered

2010-08-24

Start date

2011-04-04

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This study will involve taking a venous sample from both persons receiving warfarin treatment (experimental group) and persons not receiving warfarin treatment (control group). All persons are currently undergoing testing at a clinic. Samples collected are tested by laboratory staff on the experimental point of care device, commercially available device and standard laboratory reference instrument. The aim of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving warfarin treatment on an experimental device, commercially available point of care device and a standard laboratory method. It is expected that International Normalised Ratio(INR) values from the Universal Biosensors device will correlate with results obtained from the Roche CoaguChek and the laboratory reference method.

Interventions

The aim of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving warfarin treatment on an experimental device, commercially available point of care device and a standard laboratory method. This will involve taking a venous sample from both persons receiving warfarin treatment (experimental group) and persons not receiving warfarin treatment (control group). All persons are currently undergoing testing at a clinic. Samples collected are tested by laboratory staff on the experimental point of care device, commercially available device and standard laboratory reference instrument. It is expected that the persons participation does not exceed the time it takes to complete informed consent form and have a venous sample collected.

Study design

Allocation

Non-randomised trial

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Patients currently receiving warfarin treatment Patients not receiving warfarin treatment

Exclusion criteria

None

Outcome results