Differences in Coagulation Test Kits

This study has been completed.

Sponsor:

Information provided by:

Yuksek Ihtisas Hospital

ClinicalTrials.gov Identifier:

NCT01109667

First received: April 22, 2010

Last updated: NA

Last verified: January 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	April 22, 2010
Last Updated Date	April 22, 2010
Start Date ^ICMJE	January 2010
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Differences in Coagulation Test Kits
Official Title ^ICMJE	The Effects of Different Reagents on Coagulation Tests: Innovin Versus Thromborel-S.
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 Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Patients receiving and not receiving oral anticoagulant therapy
Condition ^ICMJE	Effect of Different Reagents. Oral Anticoagulant Therapy
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	350
Completion Date	March 2010
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Routine control patients receiving and not receiving oral anticoagulant therapy Exclusion Criteria: Hemolytic and/or lipemic samples were excluded.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Turkey

Administrative Information
NCT Number ^ICMJE	NCT01109667
Other Study ID Numbers ^ICMJE	EPK-235
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Yuksek Ihtisas Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yuksek Ihtisas Hospital
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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