Differences in Coagulation Test Kits

NCT ID: NCT01109667

Last Updated: 2010-04-23

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

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-03-31

Brief Summary

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The aim of this study is to assess the effect of Innovin® reagent on laboratory results when compared with the Thromborel® S.

Detailed Description

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Thromboplastins are the screening tests which are used in the diagnosis of acquired or inherited disorders of the coagulation system but still, alterations between various thromboplastin preparations in the measurements remains a problem.Blood samples are going to drawn from patients receiving and not receiving oral anticoagulant therapy (OAT) during their routine laboratory tests. Samples are subjected to analysis by using Thromborel® S and Innovin® reagents. Mean International Normalized Ratio (INR), prothrombin time and fibrinogen values are going to compared. To further study the importance of this phenomenon the cohort will be divided into three subgroups according to the INR values as Group I: Patients not receiving OAT, Group II: Patients under OAT and INR values in good therapeutic range and Group III: Patients under OAT and INR values over the therapeutic range.

Conditions

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Effect of Different Reagents. Oral Anticoagulant Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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oral anticoagulant

Patients receiving and not receiving oral anticoagulant therapy.

No interventions assigned to this group

INR Level

Group I: Patients not receiving OAT, Group II: Patients under OAT and INR values in good therapeutic range and Group III: Patients under OAT and INR values over the therapeutic range.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Routine control patients receiving and not receiving oral anticoagulant therapy

Exclusion Criteria

Hemolytic and/or lipemic samples were excluded.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuksek Ihtisas Hospital

OTHER

Sponsor Role lead

Locations

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Turkiye Yuksek Ihtisas Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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EPK-235

Identifier Type: -

Identifier Source: org_study_id

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