CA2362055A1 - A method and apparatus for predicting the presence of haemostatic dysfunction in a patient sample - Google Patents

A method and apparatus for predicting the presence of haemostatic dysfunction in a patient sample Download PDF

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Publication number
CA2362055A1
CA2362055A1 CA002362055A CA2362055A CA2362055A1 CA 2362055 A1 CA2362055 A1 CA 2362055A1 CA 002362055 A CA002362055 A CA 002362055A CA 2362055 A CA2362055 A CA 2362055A CA 2362055 A1 CA2362055 A1 CA 2362055A1
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Prior art keywords
time
profile
dependent measurement
slope
patient
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Granted
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CA002362055A
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French (fr)
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CA2362055C (en
Inventor
Cheng Hock Toh
Colin Downey
Timothy J. Fischer
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Biomerieux Inc
Original Assignee
Akzo Nobel N.V.
Cheng Hock Toh
Colin Downey
Timothy J. Fischer
Biomerieux, Inc.
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Publication of CA2362055A1 publication Critical patent/CA2362055A1/en
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Publication of CA2362055C publication Critical patent/CA2362055C/en
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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/86Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/49Blood
    • G01N33/4905Determining clotting time of blood
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A method is disclosed for predicting the presence of haemo-static dysfunction. At least one time-dependent measurement (101) on an unknown sample (103) is performed and a respective prop-erty of the sample (103) is measured over time so as to derive a time-dependent measurement profile. One or more predictor vari-ables (110), including initial slope, are defined which sufficiently define the data of the time-dependent measurement profile. A model (113) is then derived that represents the relationship between an ab-normality and a set of predictor variables (110). Subsequently, the model (113) is utilized to predict haemostatic dysfunction.

Claims (41)

1. A method for predicting the presence of haemostatic dysfunction in a patient from at least one time-dependent measurement profile, comprising:
a) performing at least one time-dependent measurement on an unknown sample and measuring a respective property over time so as to derive a time-dependent measurement profile;
b) defining one or more predictor variables which define, at least in part, the data of the time-dependent measurement profile, said one or more predictor variables including the slope of the time-dependent measurement profile prior to clot formation;
c) deriving a model that represents the relationship between the haemostatic dysfunction and the one or more predictor variables; and d) utilizing the model of step c) to predict the existence of haemostatic dysfunction in the patient.
2. A method according to claim 1, wherein said at least one time-dependent measurement profile is at least one optical profile.
3. A method according to claim 3, wherein said at least one optical profile is provided by an automated analyzer for thrombosis and hemostasis testing.
4. A method according to claim 2, wherein a plurality of optical measurements at one or more wavelengths are taken over time so as to derive said at least one optical profile, said optical measurements corresponding to changes in light transmission through the patient sample.
5. A method according to claim 2, wherein a plurality of optical measurements are taken over time so as to derive said at least one optical profile, and wherein said plurality of optical measurements are each normalized to a first optical measurement.
6. A method according to claim 3, wherein in step a) said at least one optical profile is provided automatically by said analyzer, whereby said unknown sample is automatically removed by an automated probe from a sample container to a test well, one or more reagents are automatically added to said test well so as to initiate said property changes within said sample, and the development of said property over time is automatically optically monitored so as to derive said optical data profile.
7. A method according to claim 6, wherein after step d), a predicted congenital or acquired imbalance or therapeutic condition is automatically stored in a memory of said automated analyzer and/or displayed on said automated analyzer.
8. A method according to claim 6, wherein in step d), one or more assays for confirming the existence of said congenital or acquired imbalance or therapeutic condition is automatically performed.
9. A method according to claim 8, wherein said one or more confirming assays are automatically ordered and performed on said analyzer, with results of said one or more assays being stored in a memory of said automated analyzer and/or displayed on said analyzer.
10. A method according to claim 1, further comprising:
before step a), providing a set of data from known samples, which data is used in step c) for deriving said model.
11. A method according to claim 10, wherein said data from known samples is provided by performing a plurality of assays on said known samples.
12. A method according to claim 1, wherein in step a), a plurality of time-dependent measurement profiles are derived for use in step b).
13. A method according to claim 12, wherein said plurality of time dependent measurement profiles includes at least two profiles from assays initiated with PT reagents, APTT reagents, fibrinogen reagents and TT reagents.
14. A method according to claim 1, wherein said unknown sample is a sample from a medical patient, and wherein in step d), both said model and additional patient medical data are utilized for predicting the existence of said congenital or acquired imbalance or therapeutic condition.
15. A method according to claim 14, wherein said additional patient medical data includes one or more of Fibrinogen, D-dimer or platelet count information.
16. A method according to claim 1, wherein in step (d), the prediction of haemostatic dysfunction is performed a plurality of times so as to monitor disease progression or regression in the patient.
17. A method according to claim 1, wherein the prediction of haemostatic dysfunction is a prediction of Disseminated Intravascular Coagulation.
18. A method according to claim 17, wherein said prediction of Disseminated Intravascular Coagulation is correct in at least 750 of predicted cases.
19. A method according to claim 1, wherein said time-dependent measurement profile is an optical transmission through a sample during an APTT assay.
20. A method according to claim 1, wherein said time-dependent measurement profile is an optical transmission through a sample during a PT assay.
21. A method according to claim 1, wherein in step (b), the slope of the time-dependent measurement profile is taken from end of blank time up to immediately before the initiation of clot formation or a predetermined time period.
22. A method according to claim 1, wherein said time-dependent measurement profile is an optical transmission profile and said one or more parameters includes minimum transmittance and/or clot time.
23. A method according to claim 1, wherein said predicted haemostatic dysfunction is due to one or more conditions associated with disseminated intravascular coagulation, including trauma, malignancy, surgery, aortic aneurysm rupture, and systemic inflammatory response syndrome.
24. A method according to claim 1, wherein said prediction of the existence of haemostatic dysfunction includes flagging the existence or likelihood of the haemostatic dysfunction.
25. A method according to claim 1, wherein the only predictor variable is said slope of the time-dependent measurement profile prior to clot formation.
26. A method according to claim 1, wherein the predictor variable of slope of the time-dependent measurement profile prior to clot formation is a slope which is less than about -0.0003.
27. A method according to claim 26, wherein said slope less than -0.0003 corresponds to activation of coagulation prior to initiation of clot formation.
28. A method according to claim 1, wherein the predicted haemostatic dysfunction is due to one or more of infection, trauma, major surgery, malignancy, hepatic disease, pregnancy and/or child birth, hypoxia, acidosis, lithium overdose, and graft rejection.
29. A method according to claim 24, wherein method steps (a) to (d) are performed on an automated or semi-automated analyzer, and said flagging is an alert to an individual operating said analyzer or an individual reading or evaluating the results of a test run on said analyzer, that there is a possibility or probability of haemostatic dysfunction of a patient whose test sample has been run on the analyzer and flagged.
30. A method according to claim 29, wherein said alert is an alert on a paper printout or on a monitor.
31. A method according to claim 27, wherein a slope of less than -0.0003 causes flagging of the patient sample, and wherein an increase in steepness of the slope from test to test corresponds to disease progression.
32. A method according to claim 1, wherein said patient sample is whole blood or a portion thereof.
33. A method according to claim 32, wherein said patient sample is a plasma sample.
34. A method according to claim 1, where said prediction of the existence of haemostatic dysfunction in the patient has a specificity and sensitivity greater than other tests used in diagnosing haemostatic dysfunction.
35. A method according to claim 1, wherein said haemostatic dysfunction is disseminated intravascular coagulation, and wherein said prediction of disseminated intravascular coagulation in the patient has a specificity and sensitivity greater than other tests performed for diagnosing disseminated intravascular coagulation.
36. A method according to claim 35, wherein said other tests are one or more of platelet count, determination of D-dimer level, and determination of fibrinogen level.
37. A method according to claim 1, wherein said haemostatic dysfunction predicted is disseminated intravascular coagulation, and wherein said method further comprises running platelet count, D-dimer level and/or fibrinogen level assays.
38. A method according to claim 1, wherein said slope is determined from blank time to initiation of clot formation or from blank time to a predetermined time period less than the time of initiation of clot formation, whichever is less.
39. A method according to claim 1, wherein the predictor variable of slope of the time-dependent measurement profile prior to clot formation is a slope less than about -0.0005.
40. A method according to claim 1, wherein said one.
or more predictor variables are a plurality of predictor variable further comprising one or more of a minimum of the first derivative of the profile, a time index of the minimum of the first derivative, a minimum of the second derivative of the profile, a time index of the minimum of the second derivative, a time index of the maximum of the second derivative, an overall change in the coagulation parameter during the time-dependent measurement on the unknown sample, a clotting time, a slope of the profile prior to clot formation, and a slope of the profile after clot formation.
41. A method for predicting the presence of disseminated intravascular coagulation in a patient from a time-dependent measurement profile, comprising:

a) performing a time-dependent measurement on an unknown sample and measuring a respective property over time so as to derive a time-dependent measurement profile;
b) computing the slope of the time-dependent measurement profile up to the initiation of clot formation or up to a predetermined time period less than the time of the initiation of clot formation, whichever is less;
c) computing a threshold for the parameter in c) from known positive and known negative samples which sufficiently separates positive and negative samples; and d) utilizing the threshold in step c) to predict the existence of disseminated intravascular coagulation in the patient.
CA2362055A 1999-02-04 2000-02-04 A method and apparatus for predicting the presence of haemostatic dysfunction in a patient sample Expired - Fee Related CA2362055C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US24434099A 1999-02-04 1999-02-04
US09/244,340 1999-02-04
PCT/US2000/002987 WO2000046603A1 (en) 1999-02-04 2000-02-04 A method and apparatus for predicting the presence of haemostatic dysfunction in a patient sample

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CA2362055A1 true CA2362055A1 (en) 2000-08-10
CA2362055C CA2362055C (en) 2010-07-20

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EP (1) EP1147423B1 (en)
JP (1) JP4486260B2 (en)
AT (1) ATE282208T1 (en)
AU (1) AU774889B2 (en)
CA (1) CA2362055C (en)
DE (1) DE60015726T2 (en)
ES (1) ES2231167T3 (en)
WO (1) WO2000046603A1 (en)

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DE60015726T2 (en) 2005-12-22
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EP1147423B1 (en) 2004-11-10
US20040248308A1 (en) 2004-12-09
JP4486260B2 (en) 2010-06-23
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AU774889B2 (en) 2004-07-08
CA2362055C (en) 2010-07-20

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