Differences in Coagulation Test Kits

April 22, 2010 updated by: Yuksek Ihtisas Hospital

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Turkiye Yuksek Ihtisas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients receiving and not receiving oral anticoagulant therapy

Description

Inclusion Criteria:

Routine control patients receiving and not receiving oral anticoagulant therapy

Exclusion Criteria:

Hemolytic and/or lipemic samples were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
oral anticoagulant
Patients receiving and not receiving oral anticoagulant therapy.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuksek Ihtisas Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

April 22, 2010

First Submitted That Met QC Criteria

April 22, 2010

First Posted (ESTIMATE)

April 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 23, 2010

Last Update Submitted That Met QC Criteria

April 22, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EPK-235

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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