Method and apparatus for monitoring anti-platelet agents

• US 6,613,573 B1
• Filed: 06/09/2000
• Issued: 09/02/2003
• Est. Priority Date: 02/22/1999
• Status: Expired due to Term

• Current Assignee: Haemonetics Corporation
• Original Assignee: Haemoscope Corp. (Haemonetics Corporation)
• Inventors: Cohen, Eli
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US09/591,371
• Time in Patent Office: 1,180 Days
• Field of Search: 436/63, 436/69, 422/73, 435/13, 600/368, 600/369, 73/644.1
• US Class Current: 436/69
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
• CPC Class Codes: G01N 11/162 Oscillations being torsional, e.g. produced by rotating bodies
• CPC Class Codes: G01N 11/167 Sample holder oscillates, e.g. rotating crucible
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors

Abstract

A blood coagulation analyzer, such as the Thrombelastograph® (TEG®) blood coagulation analyzer is utilized to measure continuously in real time, the clotting process from the initial fibrin formation, through platelet-fibrin interaction and lysis to generate blood coagulation parameters. The measured blood coagulation parameters permit confirmation of the attainment of therapeutic level of GPIIb/IIIa receptor blockade; individualized dosing assessment to evaluate attainment of adequate GPIIb/IIIa receptor blockade; individualized dosing assessment required to reach adequate GPIIb/IIIa receptor blockade; illustration of the rate of diminishment of platelet inhibition or inhibition recovery after treatment with platelet-inhibition drugs; evaluation of the interaction effect of a combination of thrombolytic or any other agents or conditions effecting hemostasis and platelet-inhibiting agents on patient hemostasis.

Claims

1. An apparatus for measuring the efficacy of an anti-platelet therapy comprising:

a blood coagulation analyzer operable to measure a first blood sample in the absence of the anti-platelet therapy and a second blood sample in the presence of the anti-platelet therapy to respectively generate a first blood coagulation parameter and a second blood coagulation parameter, wherein the first blood coagulation parameter and the second blood coagulation parameter are related to blood clot strength; and

a processor operatively coupled to the blood coagulation analyzer, the processor having an associated control program for directing the operation of the processor for determining an efficacy of the anti-platelet therapy based upon the first blood coagulation parameter and the second blood coagulation parameter, wherein at least one of the first blood coagulation parameter and the second blood coagulation parameter is based upon a characteristic of an as sampled portion of the respective blood sample and a characteristic of a portion of the respective blood sample treated in vitro to inhibit thrombin activation and to preserve fibrinogen and platelet activation.

2. The apparatus of claim 1, wherein each of the first blood coagulation parameter and the second blood coagulation parameter is based upon a characteristic of an as sampled portion of the respective blood sample and a characteristic of a portion of the respective blood sample treated in vitro to inhibit thrombin activation and to preserve fibrinogen and platelet activation.

3. The apparatus of claim 1, wherein the blood coagulation analyzer has a clot strength sensitivity in the range of about 100 dyn/cm² to about 1000 dyn/cm².

4. The apparatus of claim 1, wherein the blood coagulation analyzer includes a first testing station and a second testing station, the first and second testing stations operable substantially simultaneously on the first blood sample and the second blood sample, respectively.

5. The apparatus of claim 4, wherein the first testing station has a first clot strength sensitivity and the second testing station has a second clot strength sensitivity.

6. The apparatus of claim 1, wherein the processor and control program are further operable to generate data for providing a visual representation of the first and second blood coagulation parameters.

7. The apparatus of claim 1, wherein the processor and control program are further operable to generate a dosing recommendation associated with the anti-platelet therapy.

8. The apparatus of claim 1, wherein at least one of the first and second blood coagulation parameters relate to a blood coagulation therapy comprising one of:

an anti-coagulation therapy utilizing the administration of heparin or warfarin;

a thrombolytic therapy utilizing the administration of tPA, streptokinase or urokinase;

an antifibrinolytic therapy utilizing ε

-amino-caproic acid or trasylo, tranexamic acid;

an anti-platelet therapy; and

a blood component transfusion therapy.

9. The apparatus of claim 1, wherein at least one of the first and second parameters relate to a thrombotic risk assessment including a hypercoagulable condition assessment and an excessive bleeding risk including hypocoagulable assessment.

10. A method of measuring the efficacy of an anti-platelet therapy comprising the steps of:

providing a blood coagulation analyzer, the blood coagulation analyzer capable of measuring a clot strength;

determining a first blood coagulation parameter of a first blood sample obtained in the absence of the anti-platelet therapy using the blood coagulation analyzer;

determining a second blood coagulation parameter of a second blood sample obtained in the presence of the anti-platelet therapy using the blood coagulation analyzer;

wherein at least one of the first blood coagulation parameter and the second blood coagulation parameter is based upon a characteristic of an as sampled portion of the respective blood sample and a characteristic of a portion of the respective blood sample treated in vitro to inhibit thrombin activation and to preserve fibrinogen and platelet activation; and

determining an efficacy of the anti-platelet therapy based on the first and second blood coagulation parameters.

11. The method of claim 10, wherein the blood coagulation analyzer is operable to measure a clot strength in the range of about 100 dyn/cm² to about 1000 dyn/cm².

12. The method of claim 10, wherein the blood coagulation analyzer provides for the substantially simultaneous testing of the first and second blood samples.

13. The method of claim 10, performed in conjunction with the administration of at least one of the following blood coagulation therapies:

anti-coagulation therapy utilizing the administration of heparin or warfarin;

a thromolytic therapy utilizing the administration of tPA, streptokinase or urokinase;

an antifibrinolytic therapy utilizing e-amino-caproic acid, trasylol or tranexamic acid;

an anti-platelet therapy and a blood component transfusion therapy.

14. The method of claim 10, wherein the method is performed in connection with assessment of thrombotic risk.

15. The method of claim 10, wherein the method is performed in connection with one of an assessment of a hypercoagulable condition and a hypocoagulable condition.

16. The method of claim 10, further comprising the step of determining a dosing of an anti-platelet agent.

17. The method of claim 10, wherein the blood coagulation analyzer comprises processing capability, and wherein the step of determining an efficacy is performed by the blood coagulation analyzer.

18. The method of claim 10, wherein the first and second blood coagulation parameters are based upon one of:

a latency period to clot formation, a rate of clot formation, a maximum clot strength and rate of clot lysis.

19. The method of claim 10, wherein the first and second blood coagulation parameters correspond to an estimate of fibrin-platelet interaction.

20. The method of claim 10, wherein the first blood coagulation parameter is represented by a first maximum amplitude measurement and the second coagulation parameter is represented by a second maximum amplitude measurement, and wherein the step of determining an efficacy comprises comparing the first maximum amplitude with the second maximum amplitude.