WO2018086952A1

WO2018086952A1 - Multi-parameter blood transfusion advisor

Info

Publication number: WO2018086952A1
Application number: PCT/EP2017/077836
Authority: WO
Inventors: Minnan XU
Original assignee: Koninklijke Philips NV
Current assignee: Koninklijke Philips NV
Priority date: 2016-11-10
Filing date: 2017-10-30
Publication date: 2018-05-17
Anticipated expiration: 2019-05-10

Abstract

A method (100) for providing a blood transfusion recommendation for a subject (210) includes the steps of: (i) providing (110) a blood transfusion recommendation system (200) comprising a processor (212); (ii) receiving (120), by the processor, two or more subject inputs each comprising information about the subject; (ii) calculating (130) a blood transfusion recommendation by the processor based on the received two or more subject inputs; and (iii) providing (140) the blood transfusion recommendation to a user (260).

Description

MULTI-PARAMETER BLOOD TRANSFUSION ADVISOR

Technical Field

[0001] The present disclosure relates to methods and systems for evaluating multiple subject parameters in order to provide a healthcare provider with a blood transfusion recommendation.

Background

[0002] Blood transfusion is the process of receiving blood or blood products from a donor. In some cases, the blood or blood products can be provided by the recipient at an earlier time and stored for the later transfusion. Blood transfusion is a common intervention in the acute care setting, and is often provide to patients with anemia or to patients who are bleeding as a result of surgery or trauma. Anemia, for example, is very common in the intensive care unit. Approximately 95% of intensive care (ICU) patients have abnormally low hemoglobin levels by ICU day three.

[0003] Blood transfusion indicators, which indicate to a healthcare provider that a blood transfusion is warranted, are usually hemoglobin (Hgb) and hematocrit (HCT). Hemoglobin is the iron-containing protein that makes up approximately 96% of the content by weight of red blood cells. The amount of hemoglobin in the blood is readily measurable, and is most often reported in grams per deciliter (g/dL). Hematocrit is the volume percentage (vol%) of red blood cells in blood, and is normally approximately 45% for males and 40% for females.

[0004] The impact of blood transfusion on mortality and other clinically relevant outcomes is complex, and varies with patient age, disease groups, and other patient characteristics. One of the most commonly used transfusion triggers or thresholds for anemia, for example, is 30/10, which refers to an HCT of < 30% and/or an Hgb of < 10 g/dL. Recent evidence, however, suggests that more conservative transfusion thresholds - such as Hgb < 7 g/dL - should be applied to critically ill patients, because red blood cell transfusions > 7 g/dL in a variety of patient populations has actually shown harm to the patient. For example, adverse effects of transfusion therapy include hospital acquired infections, immunological impairment, lung injury, hemolytic reactions, and higher cancer incidence. As a result, unnecessary transfusions contribute to wasteful heath care expenditures. [0005] HCT and/or Hgb alone do not provide the most efficient or accurate transfusion indicators. A HCT and/or Hgb measurement, for example, fails to reflect plasma volume, and both HCT and Hgb concentrations can change drastically with plasma volume. For example, a simple postural change from standing to lying down can mobilize enough fluid from the leg to the torso to alter a HCT value such that a blood transfusion can be indicated. Further, HCT and Hgb are poor indicators of tissue perfusion. An Hgb value could be low, but if a patient can increase cardiac output to compensate, this patient would not benefit from blood transfusions.

Summary

[0006] In view of the foregoing, it would be beneficial to provide methods and systems that utilize multiple subject parameters, in addition to hematocrit and hemoglobin measurements, in order to provide a healthcare provider with a blood transfusion recommendation.

[0007] Accordingly, the present disclosure is directed to methods and systems for evaluating multiple parameters and/or measurements in order to provide a blood transfusion recommendation. Various embodiments and implementations herein are directed to a device or system that receives input including patient vital data, lab results, and/ or demographic data, and outputs a transfusion indication score which indicates the system's confidence that a transfusion would be appropriate for the patient. The system can also provide an indication of which of the inputs contributed to the transfusion indication score, or which were the largest contributor or contributors to the score. The transfusion indication score can be calculated by, for example, comparing clinical rules against the provided inputs, and/or by applying a recommendation algorithm developed by applying machine- learning concepts to a large clinical database to discern the features among the input that are relevant to transfusion indication score. Examples of inputs can include, but are not limited to, heart rate, blood pressure, Sa0₂, Sv0₂, HCT, Hgb, lactate, fluid balance, central venous pressure, age, patient history, one or more indications of comorbidities, cardiac output changes, ECG signs for myocardial ischemia, tachycardia, compensatory mechanisms, duration of anemia, and hemodynamic status, among many others.

[0008] Generally in one aspect, a method for providing a blood transfusion recommendation for a subject is provided. The method includes the steps of: (i) providing a blood transfusion recommendation system comprising a processor; (ii) receiving, by the processor, two or more subject inputs comprising information about the subject; (iii) calculating, by the processor and based on the received two or more subject inputs, a blood transfusion recommendation; and (iv) providing the blood transfusion recommendation to a user.

[0009] According to an embodiment, the two or more subject inputs comprise a hematocrit measurement, a hemoglobin measurement, and at least one other measurement. According to an embodiment, the two or more subject inputs comprise information other than a hematocrit measurement or a hemoglobin measurement. According to an embodiment, the two or more subject inputs comprise at least one subject vital sign measurement, one laboratory result, and demographic information about the subject.

[0010] According to an embodiment, the blood transfusion recommendation comprises a transfusion indication score.

[0011] According to an embodiment, the blood transfusion recommendation comprises an output comprising at least one of the two or more subject inputs, wherein the at least one of the two or more subject inputs contributed to the blood transfusion recommendation.

[0012] According to an embodiment, the method further includes the step of monitoring, by the processor, a response of the subject to the recommended blood transfusion.

[0013] According to an embodiment, the method further includes the step of communicating, to a user, the response of the subject to the recommended blood transfusion.

[0014] According to an aspect is a device for providing a blood transfusion recommendation for a subject. The device includes: a display configured to provide a blood transfusion recommendation to a user; and a processor configured to: (i) receive two or more subject inputs, the subject inputs comprising information about the subject; (ii) calculate, based on the received two or more subject inputs, a blood transfusion recommendation; and (iii) cause the display to provide the blood transfusion recommendation to the user.

[0015] According to an aspect is a method for providing a blood transfusion recommendation for a subject. The method includes the steps of: (i) providing a blood transfusion recommendation system comprising a processor, and a display configured to provide the blood transfusion recommendation to a user; (ii) receiving, by the processor, two or more subject inputs, the subject inputs comprising information about the subject, wherein the two or more subject inputs comprise at least one subject vital sign measurement, one laboratory result, and demographic information about the subject; (iii) calculating, by the processor and based on the received two or more subject inputs, a blood transfusion recommendation; and (iv) providing, via the display, the blood transfusion recommendation to a user, wherein the blood transfusion recommendation comprises a transfusion indication score.

[0016] As used herein for purposes of the present disclosure, the term "processor" is used generally to describe various apparatus components relating to the operation of the recommendation apparatus, system, or method. A processor can be implemented in numerous ways (e.g., such as with dedicated hardware) to perform various functions discussed herein. A "processor" can employ one or more microprocessors that may be programmed using software (e.g., microcode) to perform various functions discussed herein. A processor may also be implemented as a combination of dedicated hardware to perform some functions. Examples of processor components that may be employed in various embodiments of the present disclosure include, but are not limited to, conventional microprocessors, application specific integrated circuits (ASICs), and field-programmable gate arrays (FPGAs).

[0017] In various implementations, a processor may be associated with one or more storage media (generically referred to herein as "memory," e.g., volatile and non-volatile computer memory such as RAM, PROM, EPROM, and EEPROM, floppy disks, compact disks, optical disks, magnetic tape, etc.). In some implementations, the storage media may be encoded with one or more programs that, when executed on one or more processors and/or controllers, perform at least some of the functions discussed herein. Various storage media may be fixed within a processor or controller or may be transportable, such that the one or more programs stored thereon can be loaded into a processor or controller so as to implement various aspects discussed herein. The terms "program" or "computer program" are used herein in a generic sense to refer to any type of computer code (e.g., software or microcode) that can be employed to program one or more processors or controllers. As used herein, the term "non-transitory machine-readable medium" will be understood to encompass both volatile and non-volatile memories, but to exclude transitory signals.

[0018] The term "user interface" as used herein refers to an interface between a human user or operator and one or more devices that enables communication between the user and the device(s). Examples of user interfaces that may be employed in various implementations of the present disclosure include, but are not limited to, switches, potentiometers, buttons, dials, sliders, track balls, display screens, various types of graphical user interfaces (GUIs), touch screens, microphones and other types of sensors that may receive some form of human-generated stimulus and generate a signal in response thereto.

[0019] Various embodiments may further include non-transitory computer-readable storage media, having embodied thereon a firewall program executable by a processor to perform methods described herein.

[0020] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the subject matter disclosed herein. In particular, all combinations of claimed subject matter appearing at the end of this disclosure are contemplated as being part of the inventive subject matter disclosed herein.

[0021] These and other aspects of the embodiments disclosed herein will be apparent from and elucidated with reference to the embodiment(s) described hereinafter.

Brief Description of the Drawings

[0022] In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating various principles.

[0023] FIG. 1 is a flowchart of a method for evaluating multiple parameters and/or measurements in order to provide a blood transfusion recommendation, in accordance with an embodiment.

[0024] FIG. 2 is a schematic representation of a blood transfusion recommendation engine, device, or system, in accordance with an embodiment.

[0025] FIG. 3 is a schematic representation of a blood transfusion recommendation display, in accordance with an embodiment.

[0026] FIG. 4 is a schematic representation of a blood transfusion recommendation display, in accordance with an embodiment.

Detailed Description of Embodiments

[0027] The present disclosure describes various embodiments of a method and system for providing a blood transfusion recommendation to a healthcare provider. More generally, Applicant has recognized and appreciated that it would be beneficial to provide a blood transfusion recommendation device or system that receives input about a patient and provides a blood transfusion recommendation to a healthcare provider. A particular goal of utilization of certain embodiments of the present disclosure is to provide a blood transfusion recommendation to a healthcare provider that considers factors other than HCT and/or Hgb, and that prevents the possible adverse effects of transfusion therapy.

[0028] In view of the foregoing, various embodiments and implementations are directed to a method and system that receives multiple inputs, including one or more measurements, about a patient and outputs a transfusion indication score which indicates the system's confidence that a transfusion is indicated. Examples of inputs utilized to determine the transfusion indication score include, but are not limited to, heart rate, blood pressure, Sa0₂, Sv0₂, HCT, Hgb, lactate, fluid balance, central venous pressure, age, patient history, one or more indications of comorbidities, cardiac output changes, ECG signs for myocardial ischemia, tachycardia, compensatory mechanisms, duration of anemia, and hemodynamic status, among many others.

[0029] According to an embodiment, the blood transfusion recommendation device or system is used in conjunction with the healthcare provider's decision-making process. For example, there will be situations where the need for a blood transfusion is obvious and a recommendation system is unnecessary, such as an acute condition where the patient is bleeding profusely. In other situations, however, the blood transfusion recommendation device or system monitors the patient continuously and provides continuous or periodic feedback or information to the healthcare provider, which the provider can then incorporate into the decision-making process. Another benefit of the recommendation system is that it can integrate and consider an enormous amount of clinical information that the healthcare provider would need significant amounts of time to review and interpret. The recommendation system also provides additional evidence for or against transfusion which is only available after analyzing and incorporating data from large clinical databases.

[0030] Referring to FIG. 1, in one embodiment, is a method 100 for providing a blood transfusion recommendation about a patient or subject. The patient or subject can be anyone in a setting or with a condition, emergency, wound, or other situation that may suggest or indicate a blood transfusion now and/or in the near future. The most common settings would be emergency rooms, operating rooms, intensive care units, field hospitals, emergency transportation vehicles, and similar locations, among many other possible settings. At step 110 of the method, a blood transfusion recommendation system or device is provided. The blood transfusion recommendation device or system may be any of the systems described or otherwise envisioned herein, including but not limited to system 200 in FIG. 2.

[0031] At step 120 of the method, the blood transfusion recommendation device or system receives multiple inputs about the patient. According to an embodiment, the inputs are measurements, parameters, and/or characteristics from, of, or about the patient or subject. Examples of possible inputs include, but are not limited to, the traditional inputs of hemoglobin (Hgb) and hematocrit (HCT), heart rate, blood pressure, percentage of oxygen saturation of arterial blood (Sa0₂), percentage of oxygen saturation of venous blood (Sv0₂), lactate, fluid balance, central venous pressure, age, patient history, indications of comorbidities, cardiac output, changes in cardiac output over time, ECG, signs of myocardial ischemia, tachycardia compensatory mechanisms, duration of anemia, and hemodynamic status, among many, many others. Accordingly, the multiple inputs about the patient can include one or more of a vital sign measurement (heart rate, blood pressure, temperature, Sa0₂, Sv0₂, and others), a laboratory result (HCT, Hgb, lactate, and others), and/or demographic information (age, comorbidities, history, and others).

[0032] At step 130 of the method, the blood transfusion recommendation device or system analyzes the two or more inputs and calculates a recommendation, such as transfusion indication score 310. According to an embodiment, the blood transfusion recommendation device or system utilizes two more inputs other than or in addition to HCT and Hgb to determine the blood transfusion recommendation. The utilized two or more inputs can be any combination of one or more vital sign measurements, one or more laboratory results, and/or one or more pieces of demographic information.

[0033] According to an embodiment, the blood transfusion recommendation device or system utilizes one or more programmed or predetermined rules to evaluate the two or more inputs and to calculate the transfusion indication score. For example, the programmed or predetermined rules can be determined or programmed as a default, and can be modified by a manufacturer, supplier, or healthcare provider, among others. The modification could be based on experience, new experimental data, the patient or subject, institutional preferences, and/or many other factors. As just one example, a default rule could be one or more of Hgb concentration < 7 g/dL, HCT < 30%, and/or Sa0₂ - Sv0₂ (0₂ extraction) >= approximately 50%, as that typically identifies the threshold for impaired tissue oxygenation. Other factors that could be utilized in the rules include central venous pressure, lactate concentration, fluid balance, and others. The transfusion indication score 310 could be determined by one programmed or predetermined rule, or a combination of two or more programmed or predetermined rules. The programmed or predetermined rule could also be specific to one or more demographic characteristics of the subject, such as sex, age, height, weight, comorbidities, and many other factors. These rules could be derived experimentally, or could be mined from datasets or research studies.

[0034] According to another embodiment, the blood transfusion recommendation device or system utilizes a recommendation algorithm to evaluate the two or more inputs and to calculate the transfusion indication score. For example, the recommendation algorithm could be preprogrammed or could be learned over time, such as through machine learning using a dataset. For example, the system could be trained using data from a large clinical database such as MIMIC or eRI, among others. Factors which could be analyzed by the learning algorithm include, but are not limited to, cardiac output changes, either measured or estimated, lactate, patient history, comorbidities such as kidney disease or coronary artery disease, evidence of heart disease such as ECG data, tachycardia or other arrhythmias, anemia, hemodynamic status, age, disease progression or state such as cardiac patient or cancer patient, and many others.

[0035] At step 140 of the method, the blood transfusion recommendation device or system provides the recommendation to the healthcare provider. The recommendation is provided to the healthcare provider using any method or means capable of communicating information. For example, the recommendation can be, for example, a transfusion indication score 310, and can be provided to the healthcare provider via a bedside display and/or handheld device. Other methods of communication include a printout, graphical display, text message, sound, alert, or any other communication method. According to an embodiment, the recommendation comprises a number, an icon, or other indication of the need or lack of a need for a blood transfusion.

[0036] According to an embodiment, the recommendation comprises information about which of the programmed or predetermined rules, if any, have been satisfied to trigger a transfusion indication. For example, the recommendation may comprise an indication that Hgb has fallen below 7 g/dL, and/or that it is currently 6.5 g/dL and a transfusion is recommended. As another example, the recommendation may comprise an indication that Sa0₂ - Sv0₂ is below 50%, and/or that it is currently 48% and a transfusion is recommended.

[0037] According to an embodiment, the recommendation comprises information about which of the factors, parameters, measurements, or demographic information was utilized in the analysis, and/or which weighed most heavily toward the transfusion recommendation. For example, the communicated recommendation may provide an indication that the cardiac condition of the patient, her age, and the Hgb concentration all factored most heavily toward the transfusion recommendation. As another example, the communicated recommendation may provide an indication that the recent history and age of the subject weighed most heavily against a transfusion recommendation. The factors may be communicated as text, a graphical representation, an icon, and/or via many other communication methods.

[0038] At optional step 150 of the method, the blood transfusion recommendation device or system monitors the effect of the recommended blood transfusion on the subject. The monitoring can be performed in order to provide information to the healthcare provider, and/or to modify or improve the recommendation system for future recommendations. For example, the healthcare provider may use the monitoring information to ensure that the subject responds favorably to the transfusion. As another example, the system may use the monitoring information to learn that the transfusion had a positive effect on the subject, thus reinforcing the decision-making process or algorithm that led to the recommendation for a transfusion. Alternatively, the system may use the monitoring information to learn that the transfusion had a negative effect on the subject, thus leading the decision-making process or algorithm to modify future recommendations or analysis under a similar set of facts.

[0039] According to an embodiment, the blood transfusion recommendation device or system monitors one or more vital signs (heart rate, blood pressure, temperature, Sa0₂, Sv0₂, and others), laboratory results (HCT, Hgb, lactate, lactate, PTT, fibrinogen, and others), and/or other measurements, parameters, or characteristics.

[0040] The blood transfusion recommendation device or system can store the subsequent monitoring information, and/or can communicate the information to the healthcare provider using any of the communication methods or means described or otherwise envisioned herein. For example, the system may report to the provider that "Subject's Hgb is 7.5 g/dL at 2 hours posttransfusion," or "No adverse reaction(s) to transfusion has been reported or detected at 5 hours post-transfusion," or "Subject J. Smith's Hgb has decreased to 6.0 g/dL at 1 hour post-transfusion." Many other data points or pieces of information are possible. According to one embodiment, information is only communicated to the provider if a predetermined or programmed threshold is satisfied, at certain time points, and/or only if the monitoring information indicates that the subject is not responding favorably to the transfusion.

[0041] At optional step 160 of the method, the blood transfusion recommendation device or system tracks the healthcare provider's use of the device or system. The tracking information could include data about the subject, the subject's condition, the transfusion recommendation, the transfusion analysis, historical information, vital signs, lab results, demographics, and/or other information.

[0042] According to one embodiment, the tracking information can be utilized as feedback to the system. For example, the fact that a provider rejects a transfusion recommendation under a set of conditions suggests to the system that the set of conditions are not optimal for a transfusion recommendation.

[0043] According to one embodiment, the tracking information can be utilized to monitor the healthcare provider's adherence to organizational protocols. For example, it may be required by an organization that a healthcare provider always administer a blood transfusion under a certain set of conditions, such as HCT and/or Hgb measurements, in addition to many other possible factors, lab results, demographic information, or other information. If the tracking information indicates that the healthcare provider is not administering the blood transfusion pursuant to the requirement, the requirement and/or the provider may need review.

[0044] According to one embodiment, the tracking information can be utilized to monitor the organization's use of blood products. For example, the blood transfusion recommendation device or system can track whenever red blood cells are recommended and applied, and can report this usage on a minute-by-minute, hourly, and/or daily basis, in addition to any other timeframe. The blood transfusion recommendation device or system may also or alternatively report when a certain amount of blood product has been recommended and/or utilized.

[0045] Referring to FIG. 2 is a blood transfusion recommendation device or system 200. The blood transfusion recommendation device or system may be any of the systems described or otherwise envisioned herein. Blood transfusion recommendation device or system 200 monitors a subject 210. The patient or subject 210 can be anyone in a setting or with a condition, emergency, wound, or other situation that may suggest or indicate a blood transfusion now and/or in the near future. The most common settings would be emergency rooms, operating rooms, intensive care units, field hospitals, emergency transportation vehicles, and similar locations, among many other possible settings.

[0046] According to an embodiment, the blood transfusion recommendation device or system 200 comprises a processor 212 which is configured or programmed to receive one or more signals from a sensor 214, an internal database 220, a user interface 216, a communications module 218, a laboratory 230, and/or an external database 250, and configured or programmed to transmit a recommendation such as a transfusion indication score 310 to a display 224. The processor 212 may be programmed using software to perform various functions discussed herein, and can be utilized in combination with a memory 222 and/or database 220. Memory 222 and/or database 220 can store data, including one or more commands or software programs for execution by processor 212, as well as various types of data. For example, the memory 222 may comprise a non-transitory computer readable storage medium that includes a set of instructions that are executable by processor 212, and which cause the system to execute one or more of the steps of the methods described herein.

[0047] The blood transfusion recommendation device or system 200 also comprises a battery or power supply 226, which provides power for operation of the device. The battery or power supply 226 may be a standard AC plug receptacle for a wall outlet, or may be permanently hardwired to a power source. Additionally and/or alternatively, the battery or power supply 226 may be implemented through the use of a lithium ion battery, for example. In some embodiments, the power supply 226 may also be implemented through the use of a capacitor. It may be possible to have the power supply 226 be capable of being charged or re-charged through the use of an external power source, such as a wired and/or wireless battery charger or charging field.

[0048] According to an embodiment, the communications module 218 of the device facilitates wired or wireless communication between the blood transfusion recommendation device or system 200 and other devices and/or networks, such as network 240. The communication module 218 may be facilitated through the use of one or more antennas, for example. The communication module 218 can facilitate communication with one or more networks or with other devices, for example, by using wireless methods that are known, including but not limited to Wi-Fi, Bluetooth, 3G, 4G, LTE, and/or ZigBee, among others. For example, as shown in FIG. 2, the communication module 218 is in wired and/or wireless communication with a subject 210, most likely through a sensor or monitor obtaining information from the user, an external database 250, and a laboratory 230.

[0049] According to an embodiment, the blood transfusion recommendation device or system 200 also comprises one or more sensors 214, which may be integral to the device or may be connected to or otherwise monitoring the subject 210. The one or more sensors 214 are used to monitor and obtain sensor data, and thus evaluate a condition of the subject. The one or more sensors 14 may comprise, for example, a sensor configured to measure, determine, or derive blood pressure, heart rate, pulse, blood oxygen, body temperature, respiratory rate, heart sound, breathing sound, movement, skin moisture, or similar health measurements, and other sensors known in the art. Accordingly, the one or more sensors 214 may be a sphygmomanometer, heart rate monitor, pulse oximeter, thermometer, accelerometer, microphone, electromagnetic sensor, and/or any other type of sensor.

[0050] The blood transfusion recommendation device or system 200 may comprise a user interface 216 to receive input from a healthcare provider 260. The user interface may be a button or multiple buttons, a microphone, a key stroke input, a slider, a touchscreen, or any of a variety of other inputs. According to another embodiment, healthcare provider 260 may provide the input remotely via a computer which communicates the input to the device via network 240. [0051] The blood transfusion recommendation device or system 200 also comprises a display 224 which is utilized to provide information such as the transfusion recommendation to the healthcare provider 260, and/or to otherwise facilitate interaction between the healthcare provider and the device. The display may be, for example, an LED-based, LCD-based, or e-paper type display. In other embodiments, the display may be a touch screen display that allows the user to directly interact with the wearable device through physical contact and/or gestures.

[0052] The components of the blood transfusion recommendation device or system 200 can be connected via a single bus, and/or through one or more data transport means. As such, some components may be connected via a local microprocessor bus, and others may be connected via one or more input/output (1/0) buses.

[0053] According to an embodiment, system 200 can optionally comprise a display device 270, which may also serve as a user input device. The device 270 may be, for example, a smartphone or other portable device. According to yet another embodiment, the device 270 may be a computer such as a desktop, laptop, tablet, or other permanent or semi-permanent computing device. The device 270 may receive input from the healthcare provider 260 and may also display information to the healthcare provider 260, as described or otherwise envisioned herein.

[0054] According to an embodiment, processor 212 of the blood transfusion recommendation device or system 200 is configured to execute one or more of the steps of the methods described herein. For example, the processor can be configured to receive multiple inputs about the patient via the sensor 214, database 220, user interface 2016, and/or the network 240, including but not limited to historical data about the subject stored in the internal database 220, information about the subject 210 obtained by sensor 214, demographic or historical data obtained from the external database 250, laboratory results obtained directly or indirectly from the laboratory 230, information about the subject from the healthcare provider via the user interface 216, and many other possible inputs. According to an embodiment, the inputs are measurements, parameters, and/or characteristics from, of, or about the patient or subject. Examples of possible inputs include, but are not limited to, the traditional inputs of hemoglobin (Hgb) and hematocrit (HCT), heart rate, blood pressure, percentage of oxygen saturation of arterial blood (Sa0₂), percentage of oxygen saturation of venous blood (Sv0₂), lactate, fluid balance, central venous pressure, age, patient history, indications of comorbidities, cardiac output, changes in cardiac output over time, ECG, signs of myocardial ischemia, tachycardia compensatory mechanisms, duration of anemia, and hemodynamic status, among many, many others. Accordingly, the multiple inputs about the patient can include one or more of a vital sign measurement (heart rate, blood pressure, temperature, Sa0₂, Sv0₂, and others), a laboratory result (HCT, Hgb, lactate, and others), and/or demographic information (age, comorbidities, history, and others).

[0055] The processor 212 of the device can also be configured to analyze the two or more inputs and calculate a recommendation. According to an embodiment, the processor utilizes two more inputs other than or in addition to HCT and Hgb to determine the blood transfusion recommendation. The utilized two or more inputs can be any combination of one or more vital sign measurements, one or more laboratory results, and/or one or more pieces of demographic information. According to an embodiment, the blood transfusion recommendation device or system utilizes one or more programmed or predetermined rules to evaluate the two or more inputs and to calculate the transfusion indication score. According to another embodiment, the blood transfusion recommendation device or system utilizes a recommendation algorithm to evaluate the two or more inputs and to calculate the recommendation.

[0056] The processor 212 of the device can also be configured to provide the calculated recommendation to the healthcare provider via display 224, display device 270, and/or any other communication method or means. For example, the recommendation can be, for example, a transfusion indication score 310, and can be provided to the healthcare provider via a bedside display and/or handheld device. Other methods of communication include a printout, graphical display, text message, sound, alert, or any other communication method. According to an embodiment, the recommendation comprises a number, an icon, or other indication of the need or lack of a need for a blood transfusion.

[0057] The processor 212 of the device can also be configured to monitor the effect of the recommended blood transfusion on the subject. The monitoring can be performed in order to provide information to the healthcare provider, and/or to modify or improve the recommendation system for future recommendations. For example, the healthcare provider may use the monitoring information to ensure that the subject responds favorably to the transfusion. As another example, the system may use the monitoring information to learn that the transfusion had a positive effect on the subject, thus reinforcing the decision-making process or algorithm that led to the recommendation for a transfusion. Alternatively, the system may use the monitoring information to learn that the transfusion had a negative effect on the subject, thus leading the decision-making process or algorithm to modify future recommendations or analysis under a similar set of facts.

[0058] The processor 212 of the device can also be configured to track the healthcare provider' s use of the device or system. The tracking information could include data about the subject, the subject's condition, the transfusion recommendation, the transfusion analysis, historical information, vital signs, lab results, demographics, and/or other information. According to one embodiment, the tracking information can be utilized as feedback to the system. According to one embodiment, the tracking information can be utilized to monitor the healthcare provider's adherence to organizational protocols. According to another embodiment, the tracking information can be utilized to monitor the organization's use of blood products.

[0059] Referring to FIG. 3 is an embodiment of a display 224 of a blood transfusion recommendation system 200. According to this embodiment, the display 224 provides a transfusion indication score 310 and historical data 320 about the score over time. The transfusion indication score 310 is, for example, a score out of 100, which in this case is 95/100. A score of 100 may indicate that a transfusion is necessary, although many other scales and scores are possible. This is just one possible embodiment of the recommendation provided to the healthcare provider, and many other methods of communication are possible.

[0060] Referring to FIG. 4, in one embodiment, is a display 224 of a blood transfusion recommendation system 200. According to this embodiment, the display 224 provides a transfusion indication score 310 and transfusion indication factors 330, which can be, for example, the one or more factors that were most important or influential in making the transfusion recommendation, among other options. According to an embodiment, the blood transfusion recommendation shown in FIG. 4 may be accompanied, for example, by an alert such as a noise and/or vibration, a text message, a pager message, or any of a variety of other alerts or notifications.

[0061] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.

[0062] The indefinite articles "a" and "an," as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean "at least one." [0063] The phrase "and/or," as used herein in the specification and in the claims, should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with "and/or" should be construed in the same fashion, i.e., "one or more" of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the "and/or" clause, whether related or unrelated to those elements specifically identified.

[0064] As used herein in the specification and in the claims, "or" should be understood to have the same meaning as "and/or" as defined above. For example, when separating items in a list, "or" or "and/or" shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as "only one of or "exactly one of," or, when used in the claims, "consisting of," will refer to the inclusion of exactly one element of a number or list of elements. In general, the term "or" as used herein shall only be interpreted as indicating exclusive alternatives (i.e. "one or the other but not both") when preceded by terms of exclusivity, such as "either," "one of," "only one of," or "exactly one of."

[0065] As used herein in the specification and in the claims, the phrase "at least one," in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase "at least one" refers, whether related or unrelated to those elements specifically identified.

[0066] It should also be understood that, unless clearly indicated to the contrary, in any methods claimed herein that include more than one step or act, the order of the steps or acts of the method is not necessarily limited to the order in which the steps or acts of the method are recited.

[0067] In the claims, as well as in the specification above, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases "consisting of and "consisting essentially of shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.

[0068] While several embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, embodiments may be practiced otherwise than as specifically described and claimed. Various embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure.

Claims

What is claimed is:

1. A method (100) for providing a blood transfusion recommendation for a subject (210), the method comprising the steps of:

providing (110) a blood transfusion recommendation system (200) comprising a processor (212);

receiving (120), by the processor, two or more subject inputs, the subject inputs comprising information about the subject;

calculating (130), by the processor and based on the received two or more subject inputs, a blood transfusion recommendation; and

providing (140) the blood transfusion recommendation to a user (260).

2. The method of claim 1, wherein the two or more subject inputs comprises a hematocrit measurement, a hemoglobin measurement, and at least one other measurement.

3. The method of claim 1, wherein the two or more subject inputs comprise information other than a hematocrit measurement or a hemoglobin measurement.

4. The method of claim 1, wherein the two or more subject inputs comprise at least one subject vital sign measurement, one laboratory result, and demographic information about the subject.

5. The method of claim 1, wherein the blood transfusion recommendation comprises a transfusion indication score (310).

6. The method of claim 1, wherein the blood transfusion recommendation comprises an output comprising at least one of the two or more subject inputs, wherein the at least one of the two or more subject inputs contributed to the blood transfusion recommendation.

7. The method of claim 1, further comprising the step of monitoring (150), by the processor, a response of the subject to the recommended blood transfusion.

8. The method of claim 7, further comprising the step of communicating (140), to a user, the response of the subject to the recommended blood transfusion.

9. A device (200) for providing a blood transfusion recommendation for a subject (210), the device comprising:

a display (224) configured to provide a blood transfusion recommendation to a user

(260); and

a processor (212) configured to: (i) receive two or more subject inputs, the subject inputs comprising information about the subject; (ii) calculate, based on the received two or more subject inputs, a blood transfusion recommendation; and (iii) cause the display to provide the blood transfusion recommendation to the user.

10. The device of claim 9, wherein the two or more subject inputs comprises a hematocrit measurement, a hemoglobin measurement, and at least one other measurement.

1 1. The device of claim 9, wherein the two or more subject inputs comprise information other than a hematocrit measurement or a hemoglobin measurement.

12. The device of claim 9, wherein the two or more subject inputs comprise at least one subject vital sign measurement, one laboratory result, and demographic information about the subject.

13. The device of claim 9, wherein the blood transfusion recommendation comprises a transfusion indication score (310).

14. The device of claim 9, wherein the blood transfusion recommendation comprises an output comprising at least one of the two or more subject inputs, wherein the at least one of the two or more subject inputs contributed to the blood transfusion recommendation.

15. A method (100) for providing a blood transfusion recommendation for a subject (210), the method comprising the steps of:

providing (110) a blood transfusion recommendation system (200) comprising a processor (212), and a display (224) configured to provide the blood transfusion recommendation to a user (260);

receiving (120), by the processor, two or more subject inputs, the subject inputs comprising information about the subject, wherein the two or more subject inputs comprise at least one subject vital sign measurement, one laboratory result, and demographic information about the subject;

providing (140), via the display, the blood transfusion recommendation to a user (260), wherein the blood transfusion recommendation comprises a transfusion indication score (310).