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NCT00867646 Clinical Trial

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

Deep Vein Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00867646
Other study ID # 20080418R
Secondary ID
Status Completed
Phase N/A
First received August 1, 2008
Last updated December 14, 2009
Start date May 2008
Est. completion date August 2008

Study information
Verified date December 2009
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Warfarin continuously treated patients

Exclusion Criteria:

- Warfarin recently discontinuous treatment

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of the PTINR measured by Coaguchek and laboratory CA1500 2 Months No
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