Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT01109667
Status:
COMPLETED
Last Update Posted:
2010-04-23
First Post:
2010-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Differences in Coagulation Test Kits
Sponsor:
Yuksek Ihtisas Hospital
Organization:
Study Overview
Official Title:
The Effects of Different Reagents on Coagulation Tests: Innovin Versus Thromborel-S.
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: