Differences in Coagulation Test Kits

Yuksek Ihtisas Hospital

Status: Completed

Conditions: Oral Anticoagulant Therapy; Effect of Different Reagents.

Study type: Observational

Funder types: Other

Identifiers

NCT01109667

EPK-235

Details and patient eligibility

About

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

Full 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.

Enrollment: 350 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Routine control patients receiving and not receiving oral anticoagulant therapy

Exclusion criteria

Hemolytic and/or lipemic samples were excluded.

Trial design

350 participants in 2 patient groups

oral anticoagulant

Description:

Patients receiving and not receiving oral anticoagulant therapy.

INR Level

Description:

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.