Differences in Coagulation Test Kits

Completed

• Conditions: Effect of Different Reagents.; Oral Anticoagulant Therapy

• Registration Number: NCT01109667
• Lead Sponsor: Yuksek Ihtisas Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-04-22
• Last Update Submitted: 2010-04-22
• Study First Posted: 2010-04-23
• Last Update Posted: 2010-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Routine control patients receiving and not receiving oral anticoagulant therapy

Exclusion Criteria

Hemolytic and/or lipemic samples were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Turkiye Yuksek Ihtisas Hospital; 🇹🇷 Ankara, Turkey