Method For Determining Coagulation Activation And Device For Carrying Out Said Method

• US 20080194036A1
• Filed: 02/22/2006
• Published: 08/14/2008
• Est. Priority Date: 02/22/2005
• Status: Active Grant

• Current Assignee: Technoclone Gesellschaft M.B.H.
• Original Assignee: Technoclone Gesellschaft M.B.H.
• Inventors: Binder, Bernd
• Granted Patent: US 7,767,458 B2
• Time in Patent Office: Days
• US Class Current: 436/69
• CPC Class Codes: C12Q 1/56 involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors

Abstract

The invention relates to a method for determining the generation of thrombin or factor Xa, said generation of activated coagulation factors in various sample materials, such as whole blood or plasma with different thrombocyte quantities, being triggered by phospholipid micelles with different tissue factor contents (0 to 1000 pM). According to the invention, the generation of thrombin is determined in a coagulation machine, which can simultaneously determine classic conventional coagulation parameters. The device for carrying out the method for the parallel determination of thrombin generation and classic conventional coagulation parameters has a rotating cuvette plate, into which a cuvette ring and cuvette elements are inserted. According to the invention, at least one section of the cuvette ring contains a test station for at least two fluorescent test sets and at least four conventional test sets for coagulation, chromogenic substrates and turbidimetric analysis.

Claims

1. A procedure for the determination of thrombin or factor Xa generation wherein the generation of activated clotting factors in different sample material, as for example whole blood, plasmas with different platelet counts is initiated by phospholipid micelles with different tissue factor content (0 to 1000 pM).

2. The procedure according to claim 1 wherein it can be used for the determination of circulating micro particle.

3. The procedure according to claim 1 wherein thrombin generation is determined in a coagulating automat, which can determine at the same time also normal conventional coagulating parameters.

4. The procedure according to claim 1 for the evaluation of adjustment of a therapy with anticoagulants.

5. The procedure according to claim 1 for the determination of a thrombophilia.

6. The procedure according to claim 1 for the analysis of circulating micro particles by employment of suitable anti-bodies or deficient plasmas.

7. The procedure according to claim 1 wherein thrombin generation is determined in whole blood to which suitable protease inhibitors or respective protease inhibitor mixtures are added

8. Equipment for the execution of the procedure according to claim 3 for the parallel determination of thrombin generation by means of fluorescence measurements and of classical conventional coagulating parameters with a rotating cuvette plate wherein into the cuvette plate a cuvette ring and/or cuvette elements are placed, whereby at least in one part of the cuvette ring a measuring station for at least two fluorescence measuring positions and at least four conventional measuring positions for coagulation, chromogenic substrates and turbidimetry are positioned.