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

Completed

• Conditions: Deep Vein Thrombosis

• Registration Number: NCT00867646
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2008-08-01
• Study First Submitted QC: 2009-03-23
• Study First Posted: 2009-03-24
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-14
• Last Update Posted: 2009-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Warfarin continuously treated patients

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Exclusion Criteria

• Warfarin recently discontinuous treatment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the PTINR measured by Coaguchek and laboratory CA1500	2 Months

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan