Claims for Patent: 10,501,773

Summary for Patent: 10,501,773

Title:	Detection and classification of an anticoagulant using a clotting assay
Abstract:	In some embodiments, the invention provides methods for detecting and/or classifying an anticoagulant at a therapeutically relevant amount or higher in a patient, including subjecting a sample of a control blood component (known not to contain the anticoagulant) to a clotting assay in the presence of a Factor Xa reagent to obtain a control clotting measurement; and subjecting a sample of a blood component from a patient suspected of having the anticoagulant to the clotting assay in the presence of the Factor Xa reagent to obtain a patient clotting measurement, wherein the patient clotting measurement sample greater than the control clotting measurement indicates the presence of the anticoagulant at a therapeutically relevant amount or higher in the patient. In some embodiments, the invention includes methods for classifying an anticoagulant as an anti-Factor Xa or a direct thrombin inhibitor anticoagulant using a clotting assay in the presence of an ecarin reagent.
Inventor(s):	Zaman; Fowzia S. (Aurora, IL), Doubleday; Marc (Cary, IL)
Assignee:	Haemonetics Corporation (Braintree, MA)
Application Number:	14/813,939
Patent Claims:	1. A method for treating a patient suspected of having either an anti-Factor Xa or a direct thrombin inhibitor (DTI) anticoagulant at a therapeutically relevant amount or higher, the method comprising: a. detecting the anticoagulant by: i. obtaining a sample of a blood component from the patient, ii. performing a first viscoelastic clotting assay in the presence of a Factor Xa reagent in a first sample of a blood component from the patient to obtain a patient Factor Xa clotting measurement; iii. obtaining a control sample of a blood component that lacks an anticoagulant; iv. and performing a viscoelastic clotting assay in the presence of a Factor Xa reagent in the control sample to obtain a control Factor Xa clotting measurement; wherein the presence of the anti-Factor Xa anticoagulant and the presence of the DTI anticoagulant are capable of being detected; wherein the patient Factor Xa clotting measurement that is at least 1.25 times greater than the control Factor Xa clotting measurement indicates the presence of the anti-Factor Xa anticoagulant or the presence of the DTI anticoagulant at a therapeutically relevant amount or higher in the patient, and wherein the patient Factor Xa clotting measurement less than or equal to the control Factor Xa clotting measurement indicates the absence of both the anti-Factor Xa anticoagulant and the DTI anticoagulant at a therapeutically relevant amount or higher in the patient; and b. if the presence of the anti-Factor Xa anticoagulant or the presence of the DTI anticoagulant at a therapeutically relevant amount or higher in the patient is detected, classifying the anticoagulant by: i. obtaining a second sample of a blood component from the patient identified as having an anticoagulant at a therapeutically relevant amount or higher; ii. performing a second viscoelastic analysis clotting assay to obtain a patient ecarin clotting measurement; iii. obtaining a control sample of a blood component that lacks an anticoagulant; and iv. performing a viscoelastic clotting assay in the presence of an ecarin reagent in the control sample to obtain a control ecarin clotting measurement; wherein a patient ecarin clotting measurement that is at least 1.25 times greater than the control ecarin clotting measurement identifies the detected anticoagulant as the DTI anticoagulant in the patient, and wherein a patient ecarin clotting measurement less than or equal to the control ecarin clotting measurement identifies the detected anticoagulant as the anti-Factor Xa anticoagulant in the patient; and administering to the patient identified as having a DTI anticoagulant a therapeutically relevant amount of a reversal agent that reverses the DTI anticoagulant, or administering to the patient identified as having an anti-Factor Xa a therapeutically relevant amount of a reversal agent that reverses the anti-Factor Xa anticoagulant. 2. The method of claim 1, wherein the viscoelastic analysis is performed using a container containing the sample on an interior of the container. 3. The method of claim 2, wherein the viscoelastic analysis is performed using the container and a pin, wherein the pin moves relative to the container or the container moves relative to the pin. 4. The method of claim 2, wherein the container lacks a bottom surface. 5. The method of claim 1, wherein the patient is a human. 6. The method of claim 1, wherein the patient is undergoing a condition selected from the group consisting of: surgery, trauma, bleeding, stroke and a thromboembolic event. 7. The method of claim 1, wherein the anticoagulant is an oral anticoagulant. 8. The method of claim 1, wherein the control Factor Xa clotting measurement is a range, average or median of at least two Factor Xa clotting measurements of at least two control blood components known to lack the anticoagulant. 9. The method of claim 1, wherein the control ecarin clotting measurement is a range, average or median of at least two ecarin clotting measurements of at least two control blood components known to lack the anticoagulant. 10. The method of claim 1, wherein the reversal agent that reverses the DTI anticoagulant is selected from the group consisting of prothrombin complex concentrate (PCC) and idarucizumab. 11. The method of claim 1, wherein the reversal agent that reverses the anti-Factor Xa anticoagulant is andexanet.

Details for Patent 10,501,773

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Boehringer Ingelheim Pharmaceuticals, Inc.	PRAXBIND	idarucizumab	Injection	761025	October 16, 2015	10,501,773	2034-07-31