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Differences in Coagulation Test Kits

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01109667
First Posted: April 23, 2010
Last Update Posted: April 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yuksek Ihtisas Hospital
  Purpose
The aim of this study is to assess the effect of Innovin® reagent on laboratory results when compared with the Thromborel® S.

Condition
Effect of Different Reagents. Oral Anticoagulant Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Different Reagents on Coagulation Tests: Innovin Versus Thromborel-S.

Resource links provided by NLM:


Further study details as provided by Yuksek Ihtisas Hospital:

Estimated Enrollment: 350
Study Start Date: January 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients receiving and not receiving oral anticoagulant therapy
Criteria

Inclusion Criteria:

Routine control patients receiving and not receiving oral anticoagulant therapy

Exclusion Criteria:

Hemolytic and/or lipemic samples were excluded.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109667


Locations
Turkey
Turkiye Yuksek Ihtisas Hospital
Ankara, Turkey, 06100
Sponsors and Collaborators
Yuksek Ihtisas Hospital
  More Information

ClinicalTrials.gov Identifier: NCT01109667     History of Changes
Other Study ID Numbers: EPK-235
First Submitted: April 22, 2010
First Posted: April 23, 2010
Last Update Posted: April 23, 2010
Last Verified: January 2010

Keywords provided by Yuksek Ihtisas Hospital:
Thromboplastin, Prothrombin, Diagnostic Reagent Kits, International Normalized Ratio, Laboratory Tests.

Additional relevant MeSH terms:
Anticoagulants