# US 12,601,748 B2 · Prospective markers in traumatic brain injury (TBI)

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- Number: US 12,601,748 B2
- Document ID: US12601748B2
- Status: Granted
- Kind: B2
- Application number: 17/426,646
- Filed: 2020-01-30
- Published: 2022-04-21
- Granted: 2026-04-14
- Earliest claimed: 2019-01-31
- Assignees: Universite De Geneve
- Applicants: Universite De Geneve
- Inventors: Jean-Charles Sanchez
- Web page: https://patentgrep.com/patent/US12601748B2

## CPC

- G01N 33/6896: {Neurological disorders, e.g. Alzheimer's disease}
- G01N 33/563: involving antibody fragments
- G01N 2800/28: Neurological disorders
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- 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)

## Abstract

The invention provides an in vitro prospective method for determining a recovery outcome in one or more samples of a subject having experienced traumatic brain injury (TBI), comprising the steps of a) determining the level of at least one biomarker selected from the group consisting of H-FABP, IL-10, GFAP, NF-L and S100B; and b) comparing each level obtained under step a) with a corresponding reference value to determine the recovery outcome. The invention also provides a device comprising an assay for determining a recovering outcome in one or more samples of a subject having experienced traumatic brain injury (TBI), the assay comprising means for detecting the level of at least one biomarker selected from the group consisting of H-FABP, IL-10, GFAP, NF-L and S100B.

## Claims

### Claim 1

A method for treating a subject having experienced a mild traumatic brain injury (TBI) comprising the steps of:
a) determining the levels of IL-10 and H-FABP in one or more samples of the subject;
b) comparing each level obtained under step a) with a corresponding reference value to determine an unfavorable recovery outcome, wherein the unfavorable recovery outcome is characterized by a level of IL-10>0.388 pg/mL and a level of H-FABP>4.305 ng/mL in the one or more samples of the subject; and
c) treating the subject having the unfavorable recovery outcome under step b) with a neuroprotective agent or hypothermia;
wherein the unfavorable recovery outcome under step b) is assessed by a score of four (4) or less in accordance with the Glasgow Outcome Scale Extended (GOSE);
and wherein the method is performed on the one or more samples which are taken, independently, less than 24 hours after occurrence of the mild TBI.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the neuroprotective agent is selected from the group consisting of AC-11, acetyl-L-carnitine, acetylcholinerase inhibitors, acetylcysteine, an anti-protein-aggregation agent, simvastatin, growth hormone, rosuvastatin, statins, marijuana, β-blockers, enzogenol, cerebrolysin, nitric oxide synthase inhibitor, progesterone, ethanol, barbiturates, and erythropoietin.

### Claim 3 (depends on 1)

The method of claim 1, further comprising in step a) determining a level of GFAP in addition to the levels of IL-10 and H-FABP in the one or more samples of the subject.

### Claim 4 (depends on 1)

The method of claim 1, further comprising in step a) determining a level of S100B in addition to the levels of IL-10 and H-FABP in the one or more samples of the subject.

### Claim 5 (depends on 1)

The method of claim 1, wherein the levels of IL-10 and H-FABP obtained under step a) are combined with one or more parameters comprising age, sex, Glasgow Coma Scale (GCS), Marshall classification of traumatic brain injury, Abbreviated Injury Score (AIS) and Injury Severity Score (ISS), and/or with one or more results from diagnostic methods comprising Computerized Tomography (CT) scan and Magnetic Resonance Imaging (MRI) to determine the unfavorable recovery outcome.

### Claim 6 (depends on 5)

The method of claim 5, wherein the levels of IL-10 and H-FABP obtained under step a) are combined with one or more parameters comprising age, Marshall classification of traumatic brain injury, ISS and/or GCS to determine the unfavorable recovery outcome.

### Claim 7 (depends on 1)

The method of claim 1, wherein the one or more samples are blood, plasma, urine, saliva, tears (lachrymal fluid) or cerebrospinal fluid (CSF).

### Claim 8 (depends on 1)

The method of claim 1, wherein the one or more samples are blood.

### Claim 9 (depends on 1)

The method of claim 1, wherein the method is characterized by a sensitivity of more than 90%, more than 95%, 96% or 97% or of 100% and a specificity of more than 40%, or at least 50%, or a sensitivity of more than 95% and a specificity of at least 25%, or 28%, or 36%.

### Claim 10 (depends on 1)

The method of claim 1, wherein the method is characterized by a specificity of more than 90%, more than 95%, 96% or 97% or of 100% and a sensitivity of at least 50%.

### Claim 11 (depends on 10)

The method of claim 10, wherein the method is characterized by a sensitivity of at least 58%, 60%, 65%, or 70%.