# US 12,000,845 B2 · Method for discharging a patient from an intensive care unit

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- Number: US 12,000,845 B2
- Document ID: US12000845B2
- Status: Granted
- Kind: B2
- Application number: 17/710,369
- Filed: 2022-03-31
- Published: 2022-07-21
- Granted: 2024-06-04
- Earliest claimed: 2017-09-13
- Assignees: B.R.A.H.M.S GmbH
- Applicants: B.R.A.H.M.S GmbH
- Inventors: Aline Pehla; Stefan Kirsch; Darius Wilson
- Web page: https://patentgrep.com/patent/US12000845B2

## CPC

- G01N 33/74: involving hormones {or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors}
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- G01N 33/86: involving blood coagulating time {or factors, or their receptors}
- G01N 2800/222: Platelet disorders
- G01N 2800/50: Determining the risk of developing a disease
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention relates to a method for determining, diagnosis, prognosis, treatment guidance, treatment monitoring, risk assessment and/or risk stratification of patients with abnormal platelet levels comprising providing a sample of said patient, determining a level of proadrenomedullin (proADM) or fragment(s) thereof in said sample, wherein said level of proADM or fragment(s) thereof correlates with the abnormal platelet levels in said patient. In embodiments of the invention, a level of proADM or fragment(s) thereof of high severity indicates low platelet levels in the subject and subsequent initiating or modifying a treatment of the patient to improve said condition. In some embodiments of the invention the method comprises determining a level of one or more additional markers in a sample isolated from the patient, such as the level of platelets, the level of PCT or fragment(s) thereof, one or more markers of thrombocytopenia and/or one or more markers of an inflammatory response.

## Claims

### Claim 1

A method comprising:
a. receiving a first bodily fluid sample of a patient in an intensive care unit (ICU-patient) who has been treated for low platelet levels and/or thrombocytopenia and/or disseminated intravascular coagulation (DIC),
b. measuring a level of proADM or fragment(s) thereof in said sample,
c. wherein when the level of proADM or fragment(s) thereof is above 2.75 nmol/l±20%,
d. maintaining the patient in the ICU and initiating an additional treatment or modifying a treatment for low platelet levels and/or thrombocytopenia and/or disseminated intravascular coagulation (DIC).

### Claim 2 (depends on 1)

The method according to claim 1, wherein the bodily fluid sample is selected from the group consisting of a blood, a blood plasma, a blood serum and a urine sample.

### Claim 3 (depends on 1)

The method according to claim 1, wherein measuring a level of proADM or fragment(s) thereof comprises measuring a level of mid-regional (MR)-proADM in the sample.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the method comprises the measuring of at least one additional parameter, selected from the group consisting of procalcitonin (PCT), lactate, C-reactive protein, at least one of the clinical scores SOFA, APACHE II, or SAPS II, markers for a dysregulation of the coagulation system, platelet count, mean platelet volume (MPV), sCD14-ST, prothrombinase, antithrombin, antithrombin activity, cationic protein 18 (CAP18), von Willebrand factor (vWF)-cleaving proteases, lipoproteins in combination with CRP, fibrinogen, fibrin, B2GP1, GPIIb-IIIa, non-denatured D-dimer of fibrin, platelet factor 4, histones and a prothrombin time assay (PT-assay).

### Claim 5 (depends on 1)

The method according to claim 1, wherein the patient has received a treatment in the ICU selected from group consisting of Factor V, Factor XIII-AP, shingosine1-phosphate (S1P), thombomodulin, antibodies against tissue factor or tissue factor pre-mRNA splicing, reactive nitrogen inhibiting peptide (RNIP) fragment, TAFIa(i), procoagulant phospholipid and a thrombin inhibitor.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the patient has received treatment in the ICU selected from group consisting of antibiotic treatment, invasive mechanical ventilation, non-invasive mechanical ventilation, renal replacement therapy, vasopressor use, fluid therapy, corticosteroids, blood or platelet transfusion, splenectomy, direct thrombin inhibitors, blood thinners, lithium carbonate, folate, extracorporal blood purification and organ protection.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the patient has received treatment in the ICU selected from group consisting of corticosteroids, blood or platelet transfusion, transfusion of blood components, drugs promoting the formation of thrombocytes and a splenectomy.

### Claim 8 (depends on 1)

The method according to claim 1, wherein when the level of proADM or fragment(s) thereof is above 2.75 nmol/l±20%, the patient receives treatment in the ICU selected from group consisting of Factor V, Factor XIII-AP, shingosine-1-phosphate (S1P), thombomodulin, antibodies against tissue factor or tissue factor pre-mRNA splicing, reactive nitrogen inhibiting peptide (RNIP) fragment, TAFIa(i), procoagulant phospholipid and a thrombin inhibitor.

### Claim 9 (depends on 1)

The method according to claim 1, wherein when the level of proADM or fragment(s) thereof is above 2.75 nmol/l±20%, the patient receives treatment in the ICU selected from group consisting of antibiotic treatment, invasive mechanical ventilation, non-invasive mechanical ventilation, renal replacement therapy, vasopressor use, fluid therapy, corticosteroids, blood or platelet transfusion, splenectomy, direct thrombin inhibitors, blood thinners, lithium carbonate, folate, extracorporal blood purification and organ protection.

### Claim 10 (depends on 1)

The method according to claim 1, wherein when the level of proADM or fragment(s) thereof is above 2.75 nmol/l±20%, the patient receives treatment in the ICU selected from group consisting of corticosteroids, blood or platelet transfusion, transfusion of blood components, drugs promoting the formation of thrombocytes and a splenectomy.