WO2012122154A2

WO2012122154A2 - Systems and devices for red blood cell storage

Info

Publication number: WO2012122154A2
Application number: PCT/US2012/027840
Authority: WO
Inventors: James C. Zimring
Original assignee: Emory University; Childrens Healthcare of Atlanta Inc
Current assignee: Emory University; Childrens Healthcare of Atlanta Inc
Priority date: 2011-03-08
Filing date: 2012-03-06
Publication date: 2012-09-13
Anticipated expiration: 2013-09-08
Also published as: WO2012122154A3

Abstract

A red blood cell storage system is configured to allow ongoing introduction of nutrition and removal of waste from stored donated blood. The system includes at least one blood compartment structured to contain donated blood; at least one solution compartment structured to contain a storage solution; and a dialysis membrane disposed between the blood compartment and the solution compartment.

Description

SYSTEMS AND DEVICES FOR RED BLOOD CELL STORAGE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 61/450,172 filed

March 8, 2011, which is hereby incorporated by reference.

BACKGROUND

[0002] Transfusion of red blood cells (RBCs) is the most common invasive medical procedure performed on hospitalized patients, and it occurs approximately 15,000,000 times per year in the United States alone. In aggregate, more than 1 out of every 100 Americans receives a blood transfusion each year, most of these receiving RBC units.

[0003] All units of RBCs are stored prior to transfusion so as to allow screening for a variety of pathogens prior to infusion into recipients. In addition, storage allows for planned procedures with large inventories and the ability to match RBCs to recipients so as to provide a safe and compatible transfusion.

[0004] Currently, the FDA approves storage of RBCs in a solution of citrate, phosphate, dextrose, and adenine (CPDA-1), with or without several storage additives (e.g. Adsol). FDA guidelines require that any given storage solution result in a product with 1) less than 1% hemolysis and 2) an average post-transfusion 24 hours survival of at least 75%. Using these criteria, current storage solutions are approved for RBCs storage for a period of 42 days.

[0005] The above guidelines, and thus the development of storage solutions, have been exclusively focused upon the survival of the RBCs post-transfusion. However, a new concern arose in the last decade. The new concern focuses not on the efficacy of the transfusion regarding RBCs and oxygen delivery, but rather coincident toxicity of the unit. Koch et al. published a clinical study indicating that cardiac surgery patients had a worse medical outcome when given RBCs stored longer than 14 days, compared to those patients who receive units stored shorter than 14 days. See Koch et al. N Engl J Med 2008; 358: 1229-1239. This study has ignited an intense controversy in the field as to the dangers of transfusing older units of RBCs and has resulted in two very large clinical trials to further investigate this issue (ABLE in Canada and RECCESS in the United States).

[0006] The mechanism(s) by which stored blood may cause medical problems is unclear, although several likely players have been suggested, including Nitric Oxide (NO), oxidize phospholipids, altered adhesion molecules, and oxidation of iron. The damage that occurs to RBCs during storage has been collectively called the storage lesion, and consists of multiple and varied alterations to proteins, lipids, and carbohydrates. It is unclear which of these may be responsible for toxicity of RBC transfusion, but multiple players are likely involved. Regardless of which alteration may be damaging to the recipient, they are all the result of storing the RBCs under current approved conditions. Thus, there is a need for storage solution device and system that reduces the damages to RBCs caused by storage.

SUMMARY

[0007] The disclosure relates to a Nutrient-Waste-Dialysis (NWD) storage system. The system is configured to allow ongoing introduction of nutrition and removal of waste from stored blood.

[0008] In some embodiments, a system for red blood cell storage may include a blood compartment structured for collection and/or storage of donated blood, a solution compartment for storing a storage solution, and a dialysis membrane disposed between the blood compartment and the solution compartment. In some embodiments, the dialysis membrane may be structured to allow introduction of nutrition and removal of waste from stored blood.

[0009] In some embodiments, the system may be structured to store a volume for the storage solution greater than a volume for the donated blood. In some embodiments, the storage solution compartment may be larger than the blood compartment. The storage solution may be a nutrient storage solution.

[0010] In some embodiments, the system may include a container divided into the blood compartment and the storage solution compartment. In some embodiments, the system may include a container for each of the compartments. In some embodiments, the system may include a plurality of containers, wherein one of the containers includes a storage solution compartment and a blood compartment. The blood compartment and the solution compartment may be disposed within a single container. In some embodiments, the container may be a self-contained bag.

[0011] In some embodiments, the system may further include a dialysis membrane disposed between the blood compartment and the solution compartment. In some embodiments, the dialysis membrane may have about a 3500 molecular weight cut-off.

[0012] In some embodiments, the system may include a container having a plurality of blood compartments and storage solution compartments. In other embodiments, the system may include a container including plurality of blood compartments and a plurality of solution compartments. In other embodiments, the system may be a container having a blood compartment and a plurality of solution compartments. The plurality of blood compartments may be for a single or multiple blood units.

[0013] In some embodiments, the system may include at least three compartments, a first compartment being structured to store donated blood, a second compartment being structured to store and/or collect a storage solution, and a third compartment being structured to store one of a storage solution or donated blood; and at least one dialysis membrane disposed between the compartments. [0014] In other embodiments, the system may include a container for each compartment.

The system may include a container having a blood compartment connected to a container having a storage solution compartment.

[0015] In further embodiments, the system may include a removable protective device that is structured to shield the dialysis membrane while the blood is collected from a donor.

[0016] In some embodiments, the system may include at least one port structured to be in communication with one of the compartments. In some embodiments, the port may be a one-way valve. In other embodiments, the port may be a two-way valve. In some embodiments, the at least one port may be structured to be in fluid communication with the blood compartment. The at least one port may be structured to receive the donated blood for storage in the blood compartment. In other embodiments, the at least one port may be structured to be in fluid communication with the solution compartment. In some embodiments, the system may include a plurality of ports, each port being structured to be in communication with each compartment.

[0017] In some embodiments, the solution compartment may include the storage solution.

The solution compartment may be prepackaged with the storage solution. In some embodiments, the blood compartment may include a blood preservative.

[0018] In some embodiments, the blood compartment may be disposed adjacent to the solution compartment. In other embodiments, the blood compartment may at least partially surround the solution compartment. In other embodiments, the solution compartment may at least partially surround the blood compartment.

[0019] In some embodiments, each component of the system may be sterilized. In further embodiments, the system may be a single-use unit. In further embodiments, the system may be disposable. In some embodiments, the solution compartment may be prepackaged with a nutrient storage solution. In further embodiments, the blood compartment may be prepackaged with any known blood preservative.

[0020] In some embodiments, the storage solution may include phosphate buffered saline, glucose and adenine. In some embodiments, the storage solution may further include amino acids, nucleic acids, vitamins, lipids, carbohydrates and others. In further embodiments, the storage solution may also include chemical anti-oxidants, metal chelators, and preservative chemicals may be added to the storage solution. The storage solution may also include pathogen inactivation chemicals and any additional small molecule that may be beneficial for any issue regarding RBC storage. The storage solution may also consist of lowering glucose to physiological concentrations as opposed to the superphysiological concentrations used in current solutions. Doing so would decrease damage to RBCs from hyperglycemic storage, in particular, advanced glycation endproducts (AGEs). The enhanced volume of the NWD system would allow the same overall glucose nutrition but with a decreased concentration. DESCRIPTION OF DRAWINGS

[0021] The disclosure can be better understood with the reference to the following drawings and description. The components in the figures are not necessarily to scale, emphasis being placed upon illustrating the principles of the disclosure.

[0022] Figure 1 illustrates an example of a system according to an embodiment.

[0023] Figure 2 show the system used to demonstrate the principles behind the operation of a system according to an embodiment.

[0024] Figure 3 shows the assessment of GFP + RBCs, of post-transfusion survival of blood used in the system of Figure 2, that were enumerated post-transfusion into wild-type mice.

[0025] Figures 4 show the results of the monitoring of post-transfusion survival of blood used in the system of Figure 2 at 4 hours.

[0026] Figure 5 show the results of the monitoring of post-transfusion survival of blood used in the system of Figure 2 over a 48 hour time course.

[0027] Figure 6 shows the microparticle analysis of RBCs, stored in the system of Figure 2, that were subject to flow cytometry prior to transfusion. GFP+ events were gated on to distinguish intact cells. TER119 + events were then plotted against FSC to distinguish intact RBCs from RBCs with decreased size, including erythroid microparticles.

DETAILED DESCRIPTION OF EMBODIMENTS

[0028] The following description, numerous specific details are set forth such as examples of specific components, devices, systems, methods, etc., in order to provide a thorough understanding of the embodiments of the disclosure. It will be apparent, however, to one skilled in the art that these specific details need not be employed to practice embodiments of the disclosure. In other instances, well-known materials or methods have not been described in detail in order to avoid unnecessarily obscuring embodiments of the disclosure. While the disclosure is susceptible to various modifications and alternative forms, specific embodiments thereof are shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the disclosure to the particular forms disclosed, but on the contrary, the disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

Principle of the NWD Systems and Devices

[0029] The reasons for how and why the storage lesion occurs have been a matter of considerable debate including the effect of cold, pH, high sugar content, citrate, and aerobic vs.

anaerobic conditions. However, the disclosed storage devices and systems are based upon the principles that the storage lesion is not the result of storing RBCs under the unnatural conditions of cold, citrate, dextrose and pH at an unphysiological pH. In contrast, the principles are based on the idea that RBC storage lesion is a natural result of simple starvation and failure to eliminate natural waste.

[0030] When stored according to the current standard, in a bag of blood, the RBCs are given a limited supply of food (in this case glucose) and there is no mechanism at all to eliminate waste (in this case mostly lactate but also other waste products). Moreover, the storage solutions lack the necessary chemicals for the RBC to maintain internal molecules of essential function (i.e., the amino acids required for glutathione generation are absent). In the natural state, the liver and GI system will maintain equilibrium of nutrients in the blood, and the kidneys will efficiently eliminate waste. In a blood bag, nutrients are not supplied and waste is not removed. Although cold, stored RBCs are nevertheless living, and undergo active albeit slowed metabolism. All living things undergoing active metabolism will become damaged and ultimately die under conditions of starvation and/or failure to remove waste; this is precisely the situation in which stored RBCs are kept. Thus, if the blood is stored under conditions that provide ongoing nutrition and efficient waste removal, the storage lesion may be mitigated or eliminated.

[0031] The disclosed storage devices and systems are designed to mitigate or eliminate the storage lesion by providing ongoing nutrition and efficient waste removal. According to some embodiments, the storage of RBC may be significantly improved because the systems and devices according to the disclosure expose the stored blood to additional fluid volume to allow additional nutrients and the removal of toxic waste products. In further embodiments, the systems and devices according to the disclosure use nutrient waste dialysis (NWD) storage to achieve these benefits.

NWD Systems and Devices

[0032] In some embodiments, the RBC storage devices and systems according to the disclosure may be structured to allow ongoing introduction of nutrition and removal of waste from stored blood. In some embodiments, because the volume of intravenous fluid that is delivered to a patient may be critical issue, the system may be structured so as not to alter the volume of blood that would be transfused from the current standard of care.

[0033] In some embodiments, a device may include at least one compartment structured to collect and/or store the donated blood (hereinafter "blood compartment") and at least one compartment structured to store a storage solution (hereinafter "solution compartment"). The storage solution may be a nutrient storage solution. The nutrient storage solution may be according to embodiments or may be a different nutrient storage solution.

[0034] In some embodiments, the devices and systems may include more than two compartments. In some embodiments, the devices and systems may include three compartments, four compartments, five compartments, six compartments, etc. In some embodiments, there may be the same number of blood compartments and solution compartments. In other embodiments, there may be a different number of blood compartments and solution compartments. There may be more blood compartments than solution compartments. In other embodiments, there may be more solution compartments than blood compartments.

[0035] In some embodiments, the solution compartment may the same size as the blood compartment. In other embodiments, the solution compartment and the blood compartment may be of different sizes. In some embodiments, the solution compartment may be larger than the blood compartment. In other embodiments, the solution compartment may be smaller than the blood compartment.

[0036] In some embodiments, each compartment may be structured to directly receive donated blood or storage solution. In other embodiments, one, some, or all compartments may be structured to receive a cartridge of the blood and/or nutrient storage solution. In some embodiments, the cartridge may be a bag.

[0037] In some embodiments, the systems and devices may include a single container that includes the at least two compartments. At least one (a first compartment) of the compartments may be structured to store a storage solution and at least one (a second compartment) of the compartments may be structured to store donated blood. In some embodiments, the blood compartment may further include a blood preservative. The blood compartment may be prepackaged with the blood preservative. The blood preservative may be any known blood preservative. The preservative may include but is not limited to, sodium fluoride, sodium acetate, and sodium bicarbonate.

[0038] In some embodiments, the solution compartment may include the storage solution.

The solution compartment may be prepackaged with the storage solution.

[0039] In some embodiments, the solution compartment and the blood component may be disposed adjacent to each other. In other embodiments, the blood compartment may partially or completely surround the solution compartment. In some embodiments, the solution compartment may partially or completely surround the blood compartment.

[0040] In other embodiments, the system may include a container having a plurality of blood and/or solution compartments. For example, the container may include additional compartment(s) (for example, a third compartment) that is structured to store one of the storage solution and donated blood. In other embodiments, the system may include a container having a blood compartment and at least two solution compartments. In other embodiments, the system may include a container having a solution compartment and at least two blood compartments. The blood compartments may be for a single or multiple blood units.

[0041] In some embodiments, the system may be structured to store a volume for the storage solution greater than a volume for the donated blood. In some embodiments, the system may include more storage compartments than the blood compartment(s), a larger storage compartment than the blood compartment, or any combination thereof.

[0042] In some embodiments, the system may include a single container. In other embodiments, the system may include a plurality of containers. In some embodiments, the systems and devices may include a container for each compartment. In some embodiments, the systems and devices may include two containers. In other embodiments, the systems and devices may include more than two containers, for example, three containers, four containers, five containers, etc. In some embodiments, the system may include a plurality of containers having the same compartment configuration, containers having different compartment configurations, or a combination thereof.

[0043] In some embodiments, each compartment and/or container may be self-contained and pliable. In some embodiments, each container may be similar to existing RBC bags.

[0044] In some embodiments, the container may have any shape. In some embodiments, the container may have a circular, oval, or an asymmetric shape. In some embodiments, the container may have a shape to correspond to the blood collection and/or transfer system.

[0045] In some embodiments, each container and/or compartment may be made of a medical grade plastic material. The material may include but is not limited to polyvinyl chloride plasticized with di-2-ethylhexyl-phthalate (PVC-DEHP), citrate ester, polypropylene, or other suitable plastic materials.

[0046] The systems and devices may further include at least one dialysis membrane. The dialysis membrane may be between the blood and solution compartments. The dialysis membrane may be structured to segregate the RBCs from the larger volume of the RBCs. This configuration allows the benefits of large volume nutrient and waste exchange while maintains the RBCs in a small volume so as to allow transfusion of packed RBCs without volume overload. In some embodiments, the dialysis membrane may be structured to allow introduction of nutrition and removal of waste from stored blood.

[0047] In some embodiments, a dialysis membrane may be disposed between the blood and solution compartments within a container. In some embodiments, a dialysis membrane may be provided within a container that is in fluid communication with containers that each include a blood or solution compartment.

[0048] In some embodiments, the dialysis membrane may be constructed from porous membrane materials or fibers. The dialysis membrane may be a small molecular weight cut-off, such as a 3500 MWCO. In some embodiments, the dialysis membrane may have a molecular weight cutoff of about 3500 MWCO. In other embodiments, the dialysis membrane may have a smaller or larger molecular weight cut-off.

[0049] In some embodiments, the systems and devices may include at least one port. In some embodiments, each compartment may communicate with a port. In other embodiments, one of the compartments may communicate with a port. In other embodiments, each container may include a port. In other embodiments, each container may include more than one port. The ports may be of the same type, different type, or a combination thereof. The port may be one-way valve or may be a two- way valve. [0050] In some embodiments, each blood compartment may include at least one port. In some embodiment, each blood compartment may include at least two ports.

[0051] In some embodiments, each container may be in fluid connection with each other. In some embodiments, the containers may communicate by a port. In some embodiments, the systems and devices may include tubing so that each container is in fluid connection with each other.

[0052] Figure 1 illustrates an example of a system according to embodiments. As shown in

Figure 1, a system may include a container 100 divided into two compartments 110 and 120 for the blood compartment and the solution compartment, respectively. The blood compartment may be structured to collect and/or store donated blood and a solution compartment may be structured to store a nutrient storage solution. The system may further include a dialysis membrane 130 disposed between the two compartments. The system may also include at least one port 140 that is in fluid communication with the blood compartment.

[0053] This configuration may help maintain the pliability of the system. Due to the dialysis membrane separation, the volume of solution compartment may exceed the blood compartment as much as desired without diluting the RBCs in the blood compartment.

[0054] In further embodiments, the system may include a removable protective device that is structured to shield the dialysis membrane while the blood is collected from a donor.

[0055] The devices and systems are not limited to one blood compartment, one solution compartment, and one dialysis membrane, as shown in Figure 1. The devices and systems may have any number and configuration of blood compartment(s), solution compartment(s), and dialysis membrane(s) that allow the blood compartment to have a dialysis communication with a solution compartment.

[0056] In some embodiments, there may be multiple blood compartments connected to the solution compartment. Multiple blood compartments may be of a single unit or of multiple units of blood.

[0057] In some embodiments, the components of the devices and systems may be sterilized.

In further embodiments, the devices and systems may be disposable. In further embodiments, the compartments of the devices and systems (except for the blood to be transfused) may be prepackaged for single use as part of a kit. In some embodiments, the systems may be configured so that the solution compartment may be structured to receive a solution bag that may be changed periodically. In some embodiments, the solution compartment may be prepackaged with a nutrient storage solution. In further embodiments, the blood compartment may be prepackaged with any known blood preservative.

[0058] In some embodiments, the system may be designed so as not to alter the volume of blood that would be transfused from the current standard of care. The blood compartment, as well as the entire system, may also be designed so as to collect and store blood according to FDA and other healthcare guidelines. Nutrient Storage Solution

[0059] In some embodiments, as noted above, the system may include a nutrient storage solution. The nutrient storage solution may include phosphate buffered saline, glucose and adenine. In further embodiments, additional nutrients may be added to the storage solution including, but not limited to, amino acids, nucleic acids, vitamins, lipids, carbohydrates and others. In additional embodiments, chemical anti-oxidants, metal chelators, and preservative chemicals may be added to the storage solution. The storage solution may further include pathogen inactivation chemicals and any additional small molecule that may be beneficial for any issue regarding RBC storage.

[0060] In some embodiments, the storage solution may also include compositions configured to lower glucose to physiological concentrations as opposed to the superphysiological concentrations used in current solutions. Doing so would decrease damage to RBCs from hyperglycemic storage, in particular, advanced glycation endproducts (AGEs). The enhanced volume of the NWD system would allow the same overall glucose nutrition but with a decreased concentration.

Example of the Operation of the NWD Systems and Devices

[0061] It is noted that the system used in the example is not intended to approximate a product per se or to reflect a potential system for clinical use. Rather, this system was designed to specifically test the principle of operation of the disclosed systems and devices. This system tests the principle that exposing stored RBCs to extra volume of solution will both supplement nutrition and also allow the diffusion away of toxic waste products. Accordingly, this example establishes how the systems and devices according to the embodiments operate to increase the viability of the stored blood.

[0062] A system was developed according to the disclosure and tested using a murine model, which was developed to be used to model storage of human blood. RBCs were harvested from mice under conditions that mimic how human RBCs are stored. Donors that are transgenic for green fluorescent protein (GFP) were utilized. This allowed transfusion of stored blood into wild-type recipients, providing an easy method for assessing post-transfusion survival and biology of stored RBCs without otherwise altering them. This has been shown to be a powerful in vivo pre -clinical model, and mouse RBCs stored under these conditions show similar changes in surface markers and storage characteristics of stored human RBCs.

[0063] The system developed according to the system principles of the disclosure and tested had a small dialysis compartment (in this case, a slidalyzer purchased from Pierce Co). A 3500 molecular weight cut-off was chosen, as this will allow free diffusion of small molecules, but keeps small proteins (including hemoglobin) in the compartment with the stored blood. Blood was collected in standard CPDA-1 storage solution (as is used in humans) and was then placed into the dialysis compartment. The dialysis compartment was then submerged in 1 Liter of solution containing PBS, 4.5g/L glucose, and 0.25 mM adenine (see Figures 2a and 2b). This amount of glucose and adenine was chosen as it approximates the final levels found in routine blood bag storage solutions currently used in humans; however in the example, a much greater overall molar amount of glucose and adenine are available to the stored RBCs than in standard human blood bags. No citrate was added to the beaker solution as Calcium free saline was used and thus the citrate in the collection fluid was sufficient to prevent coagulation. The enclosure of RBCs in the dialysis tubing maintains the small volume of concentrated RBCs, which is an absolute necessity for transfusing without exposing the patient to excess volume.

[0064] After 21 days of storage, the blood was then transfused into wild-type C57BL/6 mice.

RBCs stored under standard human conditions were likewise transfused, as were freshly isolated RBCs. The 21 day time point was specifically chosen, as murine blood stored under standard human blood storage conditions reaches its capacity for storage (as per the established FDA guideline for human blood) after 16 days. Thus, 21 days represent outdated blood that has very poor posttransfusion survival.

[0065] The results of this study clearly demonstrated that RBCs stored in the dialysis compartment have a substantially better post-transfusion survival than do RBCs stored under standard conditions (Figures 3-5). Representative flow cytometric plots 310, 320, and 330 are shown from mice receiving fresh RBCs, RBCs from standard storage, or NWD RBCs (Figure 3). Transfused RBCs are distinguished by GFP fluorescence. Whereas RBCs under standard conditions had only a 21% survival at 4 hours compared to Fresh RBCs at 4 hours, NWD RBCs had a 62%> survival compared to Fresh RBCs (approximately 3 fold better survival with NWD storage) (Figure 4). This trend continued until at least 48 hours; Fresh RBCs were set at 100%) survival and survival of standard or NWD (PBS) were calculated as a percentage of Fresh RBC survival (Figure 5).

[0066] In addition, flow cytometric analysis of the stored RBCs (prior to transfusion) demonstrates less debris (fewer microparticles) in the NWD stored RBCs than in the RBCs stored under standard conditions. Microparticles are one of the entities believed to be involved in posttransfusion toxicity. See Figure 6. These data suggest that the NWD stored RBCs may not only have superior post-transfusion survival with longer storage times, but also may be a safer product regarding toxicities of transfusion. These findings are easily reproducible and are consistent from experiment to experiment.

[0067] While various embodiments of the disclosure have been described, the description is intended to be exemplary rather than limiting and it will be appeared to those of ordinary skill in the art that may more embodiments and implementations are possible that are within the scope of the disclosure.

Claims

CLAIMS What is claimed:

1. A system for red blood cell storage comprising:

at least one blood compartment structured to store donated blood;

at least one solution compartment structured to store a storage solution; and

a dialysis membrane disposed between the blood compartment and the solution compartment, the dialysis membrane being structured to allow introduction of nutrition and removal of waste from stored blood.

2. The system according to claim 1, wherein the storage solution compartment may be larger than the blood compartment.

3. The system according to claim 1, wherein the blood compartment and the solution compartment are disposed within a single container.

4. The system according to claim 1, wherein the dialysis membrane has about a 3500 molecular weight cut-off.

5. The system according to claim 1, further comprising:

a second blood compartment, the second blood compartment being in fluid communication with the storage compartment.

6. The system according to claim 1, further comprising:

at least one port structured to be in fluid communication with one of the compartments.

7. The system according to claim 1, wherein each compartment is self-contained.

8. The system according to claim 1, wherein the storage solution includes at least one of phosphate buffered saline, glucose or adenine.

9. The system according to claim 8, wherein the solution compartment includes the storage solution.

10. The system according to claim 1, wherein the blood compartment includes a blood preservative.

11. The system according to claim 1 , wherein the blood compartment is disposed adjacent to the solution compartment.

12. The system according to claim 1, wherein the solution compartment partially surrounds the blood compartment.

13. A system for red blood cell storage, comprising:

at least three compartments, a first compartment being structured to store donated blood, a second compartment being structured to store a storage solution, and a third compartment being structured to store one of a storage solution or donated blood; and

at least one dialysis membrane disposed between the compartments, the dialysis membrane being structured to allow introduction of nutrition and removal of waste from stored blood.

14. The system according to claim 13, wherein the system is structured to store a volume for the storage solution that is greater than a volume for the donated blood.

15. The system according to claim 13, wherein the compartments are disposed within a single container.

16. The system according to claim 13, wherein the dialysis membrane has about a 3500 molecular weight cut-off.

17. The system according to claim 13, further comprising:

a port structured to be in fluid communication with the blood compartment, wherein the port is structured to at least receive the donated blood.

18. The system according to claim 17, wherein each compartment is self-contained.

19. The system according to claim 13, wherein the storage solution includes at least one of phosphate buffered saline, glucose or adenine.

20. The system according to claim 13, wherein the system includes a prepackaged storage solution.