Differences in Coagulation Test Kits

Oral Anticoagulant Therapy Clinical Trial

Official title:

The Effects of Different Reagents on Coagulation Tests: Innovin Versus Thromborel-S.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109667
• Other study ID #: EPK-235
• Status: Completed
• Phase: N/A
• First received: April 22, 2010
• Last updated: April 22, 2010
• Start date: January 2010
• Est. completion date: March 2010

Study information

• Verified date: January 2010
• Source: Yuksek Ihtisas Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Routine control patients receiving and not receiving oral anticoagulant therapy

Exclusion Criteria:

Hemolytic and/or lipemic samples were excluded.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Effect of Different Reagents.
• Oral Anticoagulant Therapy

Locations

Country	Name	City	State
Turkey	Turkiye Yuksek Ihtisas Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Yuksek Ihtisas Hospital

Country where clinical trial is conducted

Turkey,