# US 2026/0309696 A1 · Clinical decision support system

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- Number: US 2026/0309696 A1
- Document ID: US20260309696A1
- Status: Published application
- Kind: A1
- Application number: 19/707,608
- Filed: 2026-06-15
- Published: 2026-10-08
- Earliest claimed: 2022-03-30
- Assignees: Instrumentation Laboratory Company
- Applicants: Instrumentation Laboratory Company
- Inventors: Benjamin Horev; Ethan Schonbrun; Gert Blankenstein; Luisa Andruzzi; Anne Winkler; Jacqueline Scott
- Web page: https://patentgrep.com/patent/US20260309696A1

## CPC

- G01N 33/4905: {Determining clotting time of blood (by chemical methods G01N33/86, C12Q1/56)}
- C12Q 1/56: involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
- G01N 33/86: involving blood coagulating time {or factors, or their receptors}
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- G01N 2800/226: Thrombotic disorders, i.e. thrombo-embolism irrespective of location/organ involved, e.g. renal vein thrombosis, venous thrombosis
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

An example method includes: analyzing a clot curve for a test sample that is based on an assay performed on the test sample in order to obtain two or more parameters associated with the clot curve; analyzing the two or more parameters to determine at least one of (i) whether a fibrinogen concentration in the test sample is below a threshold, or (ii) whether there is a therapeutic or pharmaceutical anticoagulant present in the test sample; and outputting, to a user interface, information based on the determination.

## Claims

### Claim at position 1

1-20. (canceled)

### Claim 21

A system comprising:
non-transitory machine-readable memory storing instructions that are executable; and
one or more processing devices to execute the instructions to perform operations comprising:
performing an analysis based on a clot curve for a test sample, the clot curve being based on an assay performed on the test sample, the analysis being performed in order to obtain one or more parameters associated with the clot curve, the one or more parameters comprising a D′-parameter, a D″-parameter, or both the D′-parameter and the D″-parameter, wherein the D′-parameter is a difference in absorbance between time points of maximum acceleration and acceleration zero-crossing of the clot curve, and the D″-parameter is a difference in absorbance between time points of maximum acceleration and a threshold of an absorbance travel of the clot curve; and
analyzing the one or more parameters to determine whether there is an anticoagulant present in the test sample; and
outputting information based on the determination.

### Claim 22 (depends on 21)

The system of claim 21, wherein the anticoagulant is a therapeutic anticoagulant, a pharmaceutical anticoagulant, a natural anticoagulant, or a genetically-occurring anticoagulant.

### Claim 23 (depends on 22)

The system of claim 22, wherein the natural anticoagulant or genetically-occurring anticoagulant includes one or more of lupus anticoagulant, clotting factor VIII (8), clotting factor IX (9), clotting factor XI (11), or clotting factor XII (12).

### Claim 24 (depends on 21)

The system of claim 21, wherein the one or more parameters further include one or more of clot growth rate, clot formation duration, clot amplitude, clot baseline, clotting time, clot growth width, clot growth skew, or first, second, or third derivative features of the clot curve comprising one or more of clot acceleration duration and/or shape, clot deceleration duration and/or shape, clot peaks width, clot peaks width ratio, clot peaks location, clot peaks number, clot velocity, clot peaks amplitude, clot peaks area under curve, shapes of clot peaks, peaks onset shape, peak offset shape, peak skewness, peak kurtosis, width at a peak baseline, width at a peak location other than peak baseline, peaks prominence, or a parameter based on maximum and minimum acceleration of the clot curve.

### Claim 25 (depends on 21)

The system of claim 21, wherein the information comprises a recommendation to perform additional testing for the anticoagulant or wherein the information comprises an identity of the anticoagulant in the test sample.

### Claim 26 (depends on 21)

The system of claim 21, wherein the one or more processing devices are further configured to obtain the clot curve for the test sample based on an assay performed on the test sample and one of the one or more parameters is based on at least one of a first derivative of the clot curve or a second derivative of the clot curve.

### Claim 27 (depends on 21)

The system of claim 21,
wherein analyzing the one or more parameters to determine whether there is an anticoagulant present in the test sample comprises using the one or more parameters to distinguish a therapeutic or pharmaceutical anticoagulant from a natural or genetically-occurring anticoagulant.

### Claim 28 (depends on 21)

The system of claim 21, wherein analyzing the one or more parameters is performed using a model comprising machine learning techniques, neural networks, or a machine learning regressor or classifier.

### Claim 29 (depends on 28)

The system of claim 28, wherein the machine learning regressor or classifier comprises multiple regression, decision trees, random forests, neural networks, or support vector machines, or gradient boosting.

### Claim 30 (depends on 21)

The system of claim 21, wherein the one or more parameters are based on (i) one or more negative peaks of the clot peaks determined using the clot curve, or (ii) clot peak widths determined using the clot curve; and the one or more processing devices are configured to determine, based on the one or more parameters, at least whether an anticoagulant is present in the test sample.

### Claim 31 (depends on 30)

The system of claim 30, wherein the one or more processing devices are configured to obtain a second derivative of the clot curve; and determine the one or more parameters based on the second derivative of the clot curve, wherein the one or more negative peaks are in the second derivative of the clot curve.

### Claim 32 (depends on 31)

The system of claim 31, wherein the one or more processing devices are further configured to identify positive and negative peaks in the second derivative of the clot curve; identify widths of the positive and negative peaks; and determine a ratio based on the widths.

### Claim 33 (depends on 30)

The system of claim 30, wherein the one or more processing devices are configured to determine whether the anticoagulant is present in the test sample by determining a number of one or more negative peaks of the clot peaks, the anticoagulant being present when there is a single negative peak.

### Claim 34 (depends on 33)

The system of claim 33, wherein the one or more processing devices are configured to determine whether the anticoagulant is present in the test sample by comparing the ratio to a threshold, the anticoagulant being present when the ratio is below the threshold.

### Claim 35

A method performed by one or more processing devices, the method comprising:
performing an analysis based on a clot curve for a test sample, the clot curving being based on an assay performed on the test sample, the analysis being performed in order to obtain one or more parameters associated with the clot curve, the one or more parameters being selected from a D′-parameter, a D″-parameter, or both the D′-parameter and the D″-parameter, wherein the D′-parameter is a difference in absorbance between time points of maximum acceleration and acceleration zero-crossing of the clot curve, and the D″-parameter is a difference in absorbance between time points of maximum acceleration and a threshold of an absorbance travel of the clot curve; and
analyzing the one or more parameters to determine whether there is an anticoagulant present in the test sample; and
outputting information based on the determination.

### Claim 36 (depends on 35)

The method of claim 35, wherein the one or more parameters further include one or more parameters selected from clot growth rate, clot formation duration, clot amplitude, clot baseline, clotting time, clot growth width, clot growth skew, or first, second, or third derivative features of the clot curve comprising one or more of clot acceleration duration and/or shape, clot deceleration duration and/or shape, clot peaks width, clot peaks width ratio, clot peaks location, clot peaks number, clot velocity, clot peaks amplitude, clot peaks area under curve, shapes of clot peaks, peaks onset shape, peak offset shape, peak skewness, peak kurtosis, width at a peak baseline, width at a peak location other than peak baseline, peaks prominence, or a parameter based on maximum and minimum acceleration of the clot curve.

### Claim 37 (depends on 35)

The method of claim 35, wherein the information comprises one or more of:
(i) a recommendation to perform additional testing for the anticoagulant; or
(ii) an identity of the anticoagulant in the test sample.

### Claim 38 (depends on 35)

The method of claim 35, wherein the anticoagulant is a therapeutic anticoagulant, a pharmaceutical anticoagulant, a natural anticoagulant, or a genetically-occurring anticoagulant.

### Claim 39 (depends on 38)

The method of claim 38, wherein the natural anticoagulant or genetically-occurring anticoagulant includes one or more of lupus anticoagulant, clotting factor VIII (8), clotting factor IX (9), clotting factor XI (11), or clotting factor XII (12).