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Comparison Study of CoaguChek XS PT and Laboratory Innovin PT by NTUH Lab Medicine

Comparison Study of CoaguChek XS Prothrombin Time and Laboratory Innovin PT by NTUH Lab Medicine

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00867646
Enrollment
70
Registered
2009-03-24
Start date
2008-05-31
Completion date
2008-08-31
Last updated
2009-12-15

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

Conditions

Deep Vein Thrombosis

Keywords

PT, DVT

Brief summary

Comparison Study of CoaguChek XS PT and Laboratory Innovin PT by NTUH Lab Medicine

Detailed description

This trial is going to proceed in two phases: Familiarization Phase and Evaluation Phase. The Preliminary Comparison Study consists of ten (10) patients being tested with the CoaguChek system and the laboratory reference method. This preliminary study is intended to help familiarize the operator with the dosing of the CoaguChek XS PT strips and to serve as an indicator as to whether some of the variables. Evaluation Phase consists of testing seventy (70) patient samples with the CoaguChek XS system and with the laboratory method.

Interventions

None listed

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Warfarin continuously treated patients

Exclusion criteria

* Warfarin recently discontinuous treatment

Design outcomes

Primary

MeasureTime frame
Comparison of the PTINR measured by Coaguchek and laboratory CA15002 Months

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026