Method of predicting a blood dilution risk value

Abstract

The present invention provides for a clinical decision support system which makes use of a numerical model which dynamically describes a blood dilution of a blood circulation. Based on measured coagulation data and maybe other patient information, loss of hemostatic balance is predicted based on calculations of certain protein concentrations. Additionally, a calculation arrangement translates at least some of the calculated values of concentrations of human blood proteins into a risk value which risk value describes a risk of clotting and/or embolism and/or bleeding. A time development of that risk value is displayed to the user.

1 . Method of predicting a blood dilution risk value of a first blood circulation, the method comprising the steps:
 providing measured coagulation data describing a haemostatic situation of the first blood circulation at a first point in time (S 1 ),   applying the measured coagulation data as an input for a numerical model, the numerical model being a mathematical and dynamical representation of a blood dilution of the first blood circulation (S 2 ),   performing a simulation of a time development of the haemostatic situation by means of the numerical model and based on the measured coagulation data used as an input for the numerical model (S 3 ),   calculating values of concentrations of human blood proteins as an output of the simulation (S 4 ), and   translating at least some of the calculated values of the concentrations of the human blood proteins into a risk value, which risk value describes a risk of clotting and/or embolism and/or bleeding for the first blood circulation (S 5 ).   
     
     
         2 . Method according to  claim 1 ,
 wherein the calculation of the values of the concentrations of the human blood proteins is generating a predicted time development of said concentrations of human blood proteins as the output of the simulation.   
     
     
         3 . Method according to  claim 1 ,
 wherein the calculated values of the concentrations of the human blood proteins are m values of k different proteins, the method further comprising the step:   choosing n values out of the m values (S 6 ),   wherein k, m and n are integers and n<m, and   wherein only the n values are taken into account for the translation into the risk value.   
     
     
         4 . Method according to  claim 1 , further comprising the step:
 graphically displaying a calculated time development of the risk value ( 801 ) on a graphical user interface (S 7 ).   
     
     
         5 . Method according to  claim 1 ,
 wherein the at least some of the values of concentrations of human blood proteins are translated into the risk value by means of a numerical function of state variables of the numerical model.   
     
     
         6 . Method according to  claim 5   wherein the state variables of the numerical model are chosen from the group comprising concentrations of the following proteins: Alpha-2-Macroglobulin (A2M), C4BP, coagulation factor 10 (F10), F11, F13, prothrombin (F2), tissue factor, F5, F7, F8, F9, fibrinogen, fibrin, protein C, protein S, protein Z, protein Z related protein inhibitor (ZPI), alpha-1-anti-trypsin (AAT), protein C inhibitor (PCI), anti-thrombin (ATIII), PAI1, C1 inhibitor (C1inh), TAFI, TFPI, Vitronectin, plasmin, plasminogen, A2AP, thrombomodulin, uPA, tPA, the proteins' activated forms F10a, F11a, F13a, thrombin (F2a), F5a, F7a, F8a, F9a, activated protein C, and TAFIa, or   wherein the state variables of the numerical model comprise a concentration of complexes formed by at least two of the previously cited proteins (e.g FVa-FXa), or   wherein the state variables of the numerical model comprise a mass-length ratio of fibrin fibers formed in coagulation.   
     
     
         7 . Method according to  claim 5 , further comprising the step:
 using the numerical model to identify a set of most sensitive state variables in a situation of blood dilution based on at least one given sensitivity threshold (S 8 ).   
     
     
         8 . Method according to  claim 1 , further comprising the step:
 providing data about human blood protein levels of a second blood circulation at a second point in time as reference protein levels (S 9 ),   wherein at the second point in time the second blood circulation undergoes bleeding and/or clotting and/or embolism,   wherein the second point in time is before the first point in time, and   using said provided reference protein levels for the translation into the risk value for the first blood circulation (S 10 ).   
     
     
         9 . Method according to  claim 1 ,
 wherein the at least some of the values of the concentrations of the human blood proteins are translated into the risk value by calculating a speed of sealing of a hypothetical wound (S 14   a ) as the output or by calculating an extent of growth of a hypothetical thrombus as the output (S 14   b ).   
     
     
         10 . Method according to  claim 9 ,
 wherein the numerical model is a model of a time development of a hypothetical sealing of a wound of the first blood circulation, further comprising the steps:   performing the simulation of the time development of the hypothetical sealing of the wound of the first blood circulation in terms of at least one element of the group comprising: a wound surface area, interaction of tissue factors in a wound surface area with coagulation proteins in the first blood circulation, formation of fibrin fibers, and aggregation of blood platelets and/or fibrin fibers, which cover a wound surface and stop a clotting process.   
     
     
         11 . Method according to  claim 10 , further comprising the steps:
 evaluating the simulated time development of the hypothetical sealing of the wound by evaluating a time that passes between an initialization of the clotting process, i.e. a formation of the wound, and an cessation of the clotting process, i.e. a sealing of the wound.   
     
     
         12 . (canceled) 
     
     
         13 . Clinical decision support system for predicting and displaying a blood dilution risk value of a first blood circulation, the system comprising:
 a first arrangement configured to receive measured coagulation data describing a haemostatic situation of the first blood circulation at a first point in time,   a storing arrangement on which a numerical model is stored, wherein the numerical model is a mathematical and dynamical representation of a blood dilution of the first blood circulation,   a calculation arrangement configured to perform a simulation of a time development of the haemostatic situation by means of the numerical model and based on the measured coagulation data used as an input for the numerical model,   wherein the calculation arrangement is configured to calculate values of concentrations of human blood proteins as an output of the simulation, and   wherein the calculation arrangement is configured to translate at least some of the calculated values of concentrations of human blood proteins into a risk value, which risk value describes a risk of clotting and/or embolism and/or bleeding of the first blood circulation, further comprising   a display arrangement configured to display the risk value.   
     
     
         14 . Program element for predicting and displaying a blood dilution risk value of a first blood circulation, which when being executed by a processor is adapted to carry out:
 receiving measured coagulation data describing a haemostatic situation of the first blood circulation at a first point in time (S 1   a ),   applying the measured coagulation data as an input for a numerical model, the numerical model being a mathematical and dynamical representation of a blood dilution of the first blood circulation (S 2 ),   performing a simulation of a time development of the haemostatic situation by means of the numerical model and based on the measured coagulation data used as an input for the numerical model (S 3 ),   calculating values of concentrations of human blood proteins as an output of the simulation (S 4 ), and   translating at least some of the calculated values of concentrations of human blood proteins into a risk value, which risk value describes a risk of clotting and/or embolism and/or bleeding for the first blood circulation (S 5 ).   
     
     
         15 . Computer readable medium in which a program element for predicting and displaying a blood dilution risk value of a first blood circulation is stored, which, when being executed by a processor is adapted to carry out:
 receiving measured coagulation data describing a haemostatic situation of the first blood circulation at a first point in time (S 1   a ),   applying the measured coagulation data as an input for a numerical model, the numerical model being a mathematical and dynamical representation of a blood dilution of the first blood circulation (S 2 ),   performing a simulation of a time development of the haemostatic situation by means of the numerical model and based on the measured coagulation data used as an input for the numerical model (S 3 ),   calculating values of concentrations of human blood proteins as an output of the simulation (S 4 ), and   translating at least some of the calculated values of concentrations of human blood proteins into a risk value, which risk value describes a risk of clotting and/or embolism and/or bleeding for the first blood circulation (S 5 ).