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

NCT ID: NCT00867646

Last Updated: 2009-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Deep Vein Thrombosis

Keywords

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PT DVT

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Warfarin continuously treated patients

Exclusion Criteria

* Warfarin recently discontinuous treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Hospital

Principal Investigators

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Chiang Fu-Tien, PhD

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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20080418R

Identifier Type: -

Identifier Source: org_study_id