Plasmapheresis
Encyclopedia
Plasmapheresis is the removal, treatment, and return of (components of) blood plasma
from blood circulation
. It is thus an extracorporeal therapy (a medical procedure which is performed outside the body). The method is also used to collect plasma, to preserve it frozen and to keep it fresh. Finally, the frozen plasma is manufactured into a variety of medications.
The procedure is used to treat a variety of disorders, including those of the immune system, such as myasthenia gravis
, Guillain-Barré syndrome
, lupus
, and thrombotic thrombocytopenic purpura
. Dr. D. J. Wallace states that Michael Rubinstein was the first person to use plasmapheresis to treat an immune-related disorder when he "saved the life of an adolescent boy with thrombotic thrombocytopenic purpura (TTP) at the old Cedars of Lebanon Hospital
in Los Angeles in 1959". Also according to Wallace, the modern plasmapheresis process itself originated in the "[U.S.] National Cancer Institute between 1963 and 1968, [where] investigators drew upon an old dairy creamer separation technology first used in 1878 and refined by Edwin Cohn
's centrifuge marketed in 1953.
is initially taken out of the body through a needle or previously implanted catheter
. Plasma is then removed from the blood by a cell separator. Three procedures are commonly used to separate
the plasma from the blood cells:
Each method has its advantages and disadvantages. After plasma separation, the blood cells are returned to the person undergoing treatment, while the plasma, which contains the antibodies, is first treated and then returned to the patient in traditional plasmapheresis. (In plasma exchange, the removed plasma is discarded and the patient receives replacement donor plasma, albumin
, or a combination of albumin and saline
(usually 70% albumin and 30% saline). Rarely, other replacement fluids, such as hydroxyethyl starch
, may be used in individuals who object to blood transfusion but these are rarely used due to severe side-effects. Medication to keep the blood from clotting (an anticoagulant
) is given to the patient during the procedure. Plasmapheresis is used as a therapy
in particular disease
s. It is an uncommon treatment in the United States
, but it is more common in Europe
and particularly Japan
.
An important use of plasmapheresis is in the therapy of autoimmune disorders, where the rapid removal of disease-causing autoantibodies from the circulation is required in addition to other medical therapy. It is important to note that plasma exchange therapy in and of itself is useful to temper the disease process, where simultaneous medical and immunosuppressive therapy is required for long-term management. Plasma exchange offers the quickest short-term answer to removing harmful autoantibodies; however, the production of autoantibodies by the immune system must also be suppressed, usually by the use of medications such as prednisone
, cyclophosphamide
, cyclosporine, mycophenolate mofetil, rituximab
or a mixture of these.
Other uses are the removal of blood proteins where these are overly abundant and cause hyperviscosity syndrome
.
Examples of diseases that can be treated with plasmapheresis:
Aside from placing the catheter, the procedure itself has complications. When patient blood is outside of the body passing through the plasmapheresis machine, the blood has a tendency to clot. To reduce this tendency, in one common protocol, citrate
is infused while the blood is running through the circuit. Citrate binds to calcium
in the blood, calcium being essential for blood to clot. Citrate is very effective in preventing blood from clotting; however, its use can lead to life-threateningly low calcium levels. This can be detected using the Chvostek's sign or Trousseau's sign. To prevent this complication, calcium is infused intravenously while the patient is undergoing the plasmapheresis; in addition, calcium supplementation by mouth may also be given.
Other complications include:
, though the end product is used for different purposes. Most plasmapheresis is for fractionation
into other products; other blood donations are transfused with relatively minor modifications. Plasma that is collected solely for further manufacturing is called Source Plasma.
Plasma donors undergo a screening process to ensure both the donor's safety and the safety of the collected product. Factors monitored include blood pressure
, pulse
, temperature, total protein, protein electrophoresis
, health history screening similar to that for whole blood
, as well as an annual physical exam with a licensed physician or an approved physician substitute under the supervision of the physician. Donors are screened at each donation for viral diseases that can be transmitted by blood, sometimes by multiple methods. For example, donors are tested for HIV
by ELISA
, which will show if they have ever been exposed to the disease, as well as by nucleic acid methods (PCR or similar) to rule out recent infections that might be missed by the ELISA test. Industry standards require at least two sets of negative test results before the collected plasma is used for injectable products. The plasma is also treated in processing multiple times to inactivate any virus that was undetected during the screening process.
Plasma donors are typically paid cash for their donations, though this is not universal. For example, donors in the UK, Australia and New Zealand are not given financial incentives. Since the products are heavily processed and treated to remove infectious agents, the higher risk is considered acceptable. Standards for donating plasma are set by national regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Union, and by a professional organization, the Plasma Protein Therapeutics Association (or PPTA), which audits and accredits collection facilities. A National Donor Deferral Registry (NDDR) is also maintained by the PPTA for use in keeping donors with prior positive test results from donating at any facility.
Almost all plasmapheresis in the US is performed by automated methods such as the Plasma Collection System (PCS2) made by Haemonetics
or the Autopheresis-C (Auto-C) made by Fenwal, a division of Baxter International
. In some cases, automated plasmapheresis is used to collect plasma products like Fresh frozen plasma
for direct transfusion purposes, often at the same time as plateletpheresis
.
Manual method: For the manual method, approximately the same as a whole blood donation
is collected from the donor. The collected blood is then separated by centrifuge machines in separate rooms, the plasma is pressed out of the collection set into a satellite container, and the red blood cells are returned to the donor. Since returning red cells causes the plasma to be replaced more rapidly by the body, a donor can provide up to a liter of plasma at a time and can donate with only a few days between donations, unlike the 56-day deferral for blood donation. The amount allowed in a donation varies vastly from country to country, but generally does not exceed two donations, each as much as a liter, per 7-day period.
The danger with this method was that if the wrong red blood cells were returned to the donor, a serious and potentially fatal transfusion reaction could occur. Requiring donors to recite their names and ID numbers on returned bags of red cells minimized this risk. This procedure has largely become obsolete in favor of the automated method.
Automated method: The automated method uses a very similar process. The difference is that the collection, separation, and return are all performed inside a machine which is connected to the donor through a needle placed in the arm, typically the antecubital vein. There is no risk of receiving the wrong red cells. The devices used are very similar to the devices used for therapeutic plasmapheresis, and the potential for citrate toxicity is similar. The potential risks are explained to prospective donors at the first donation, and most donors tolerate the procedure well.
If a significant amount of red blood cells cannot be returned, the donor may not donate for 56 days, just as if they had donated a unit of blood. Depending on the collection system and the operation, the removed plasma may be replaced by saline
. The body will typically replace the collected volume within 24 hours, and donors typically donate up to twice a week, though this varies by country.
The collected plasma is promptly frozen at lower than -20 °C (-4 °F) and is typically shipped to a processing facility for fractionation. This process separates the collected plasma into specific components, such as albumin
and immunoglobulins, most of which are made into medications for human use. Sometimes the plasma is thawed and transfused as Fresh Frozen Plasma (FFP), much like the plasma from a normal blood donation.
Donors are sometimes immunized against agents such as tetanus
or hepatitis B so that their plasma contains the antibodies against the toxin or disease. In other donors, an intentionally incompatible unit of blood is transfused to produce antibodies to the antigens on the red cells. The collected plasma then contains these components, which are used in manufacturing of medications. Donors who are already ill may have their plasma collected for use as a positive control for laboratory testing.
Blood plasma
Blood plasma is the straw-colored liquid component of blood in which the blood cells in whole blood are normally suspended. It makes up about 55% of the total blood volume. It is the intravascular fluid part of extracellular fluid...
from blood circulation
Circulatory system
The circulatory system is an organ system that passes nutrients , gases, hormones, blood cells, etc...
. It is thus an extracorporeal therapy (a medical procedure which is performed outside the body). The method is also used to collect plasma, to preserve it frozen and to keep it fresh. Finally, the frozen plasma is manufactured into a variety of medications.
The procedure is used to treat a variety of disorders, including those of the immune system, such as myasthenia gravis
Myasthenia gravis
Myasthenia gravis is an autoimmune neuromuscular disease leading to fluctuating muscle weakness and fatiguability...
, Guillain-Barré syndrome
Guillain-Barré syndrome
Guillain–Barré syndrome , sometimes called Landry's paralysis, is an acute inflammatory demyelinating polyneuropathy , a disorder affecting the peripheral nervous system. Ascending paralysis, weakness beginning in the feet and hands and migrating towards the trunk, is the most typical symptom...
, lupus
Lupus
Lupus most commonly refers to the disease systemic lupus erythematosus.Lupus may also refer to:-Medicine:* Lupus erythematosus, a chronic autoimmune disease with several different forms...
, and thrombotic thrombocytopenic purpura
Thrombotic thrombocytopenic purpura
Thrombotic thrombocytopenic purpura is a rare disorder of the blood-coagulation system, causing extensive microscopic thromboses to form in small blood vessels throughout the body...
. Dr. D. J. Wallace states that Michael Rubinstein was the first person to use plasmapheresis to treat an immune-related disorder when he "saved the life of an adolescent boy with thrombotic thrombocytopenic purpura (TTP) at the old Cedars of Lebanon Hospital
in Los Angeles in 1959". Also according to Wallace, the modern plasmapheresis process itself originated in the "[U.S.] National Cancer Institute between 1963 and 1968, [where] investigators drew upon an old dairy creamer separation technology first used in 1878 and refined by Edwin Cohn
Edwin Joseph Cohn
Edwin Joseph Cohn was an early protein scientist. A graduate of Phillips Academy, Andover [1911], and the University of Chicago [1914, PhD 1917], he made important advances in the physical chemistry of proteins, and was responsible for the blood fractionation project that saved thousands of lives...
's centrifuge marketed in 1953.
As therapy
During plasmapheresis, bloodBlood
Blood is a specialized bodily fluid in animals that delivers necessary substances such as nutrients and oxygen to the cells and transports metabolic waste products away from those same cells....
is initially taken out of the body through a needle or previously implanted catheter
Catheter
In medicine, a catheter is a tube that can be inserted into a body cavity, duct, or vessel. Catheters thereby allow drainage, administration of fluids or gases, or access by surgical instruments. The process of inserting a catheter is catheterization...
. Plasma is then removed from the blood by a cell separator. Three procedures are commonly used to separate
Blood fractionation
Blood fractionation is the process of fractionating whole blood, or separating it into its component parts. This is typically done by centrifuging the blood.The resulting components are:...
the plasma from the blood cells:
- Discontinuous flow centrifugation: One venous catheter line is required. Typically, a 300 ml batch of blood is removed at a time and centrifuged to separate plasma from blood cells.
- Continuous flow centrifugation: Two venous lines are used. This method requires slightly less blood volume to be out of the body at any one time as it is able to continuously spin out plasma.
- Plasma filtrationFiltrationFiltration is commonly the mechanical or physical operation which is used for the separation of solids from fluids by interposing a medium through which only the fluid can pass...
: Two venous lines are used. The plasma is filtered using standard hemodialysis equipment. This continuous process requires less than 100 ml of blood to be outside the body at one time.
Each method has its advantages and disadvantages. After plasma separation, the blood cells are returned to the person undergoing treatment, while the plasma, which contains the antibodies, is first treated and then returned to the patient in traditional plasmapheresis. (In plasma exchange, the removed plasma is discarded and the patient receives replacement donor plasma, albumin
Albumin
Albumin refers generally to any protein that is water soluble, which is moderately soluble in concentrated salt solutions, and experiences heat denaturation. They are commonly found in blood plasma, and are unique to other blood proteins in that they are not glycosylated...
, or a combination of albumin and saline
Saline (medicine)
In medicine, saline is a general term referring to a sterile solution of sodium chloride in water but is only sterile when it is to be placed intravenously, otherwise, a saline solution is a salt water solution...
(usually 70% albumin and 30% saline). Rarely, other replacement fluids, such as hydroxyethyl starch
Hydroxyethyl starch
Hydroxyethyl starch is a nonionic starch derivative. It is one of the most frequently used volume expander under the trade names Hespan by B. Braun Medical Inc...
, may be used in individuals who object to blood transfusion but these are rarely used due to severe side-effects. Medication to keep the blood from clotting (an anticoagulant
Anticoagulant
An anticoagulant is a substance that prevents coagulation of blood. A group of pharmaceuticals called anticoagulants can be used in vivo as a medication for thrombotic disorders. Some anticoagulants are used in medical equipment, such as test tubes, blood transfusion bags, and renal dialysis...
) is given to the patient during the procedure. Plasmapheresis is used as a therapy
Blood transfusion
Blood transfusion is the process of receiving blood products into one's circulation intravenously. Transfusions are used in a variety of medical conditions to replace lost components of the blood...
in particular disease
Disease
A disease is an abnormal condition affecting the body of an organism. It is often construed to be a medical condition associated with specific symptoms and signs. It may be caused by external factors, such as infectious disease, or it may be caused by internal dysfunctions, such as autoimmune...
s. It is an uncommon treatment in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, but it is more common in Europe
Europe
Europe is, by convention, one of the world's seven continents. Comprising the westernmost peninsula of Eurasia, Europe is generally 'divided' from Asia to its east by the watershed divides of the Ural and Caucasus Mountains, the Ural River, the Caspian and Black Seas, and the waterways connecting...
and particularly Japan
Japan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...
.
An important use of plasmapheresis is in the therapy of autoimmune disorders, where the rapid removal of disease-causing autoantibodies from the circulation is required in addition to other medical therapy. It is important to note that plasma exchange therapy in and of itself is useful to temper the disease process, where simultaneous medical and immunosuppressive therapy is required for long-term management. Plasma exchange offers the quickest short-term answer to removing harmful autoantibodies; however, the production of autoantibodies by the immune system must also be suppressed, usually by the use of medications such as prednisone
Prednisone
Prednisone is a synthetic corticosteroid drug that is particularly effective as an immunosuppressant drug. It is used to treat certain inflammatory diseases and some types of cancer, but has significant adverse effects...
, cyclophosphamide
Cyclophosphamide
Cyclophosphamide , also known as cytophosphane, is a nitrogen mustard alkylating agent, from the oxazophorines group....
, cyclosporine, mycophenolate mofetil, rituximab
Rituximab
Rituximab, sold under the trade names Rituxan and MabThera, is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of B cells...
or a mixture of these.
Other uses are the removal of blood proteins where these are overly abundant and cause hyperviscosity syndrome
Hyperviscosity syndrome
Hyperviscosity syndrome is a group of symptoms triggered by increase in the viscosity of the blood. Symptoms of high blood viscosity include spontaneous bleeding from mucous membranes, visual disturbances due to retinopathy, and neurologic symptoms ranging from headache and vertigo to seizures and...
.
Examples of diseases that can be treated with plasmapheresis:
- Guillain-Barré syndromeGuillain-Barré syndromeGuillain–Barré syndrome , sometimes called Landry's paralysis, is an acute inflammatory demyelinating polyneuropathy , a disorder affecting the peripheral nervous system. Ascending paralysis, weakness beginning in the feet and hands and migrating towards the trunk, is the most typical symptom...
- Chronic inflammatory demyelinating polyneuropathyChronic inflammatory demyelinating polyneuropathyChronic inflammatory demyelinating polyneuropathy is an acquired immune-mediated inflammatory disorder of the peripheral nervous system. The disorder is sometimes called chronic relapsing polyneuropathy. CIDP is closely related to Guillain-Barré syndrome and it is considered the chronic...
- Goodpasture's syndromeGoodpasture's syndromeGoodpasture’s syndrome is a rare disease characterized by glomerulonephritis and hemorrhaging of the lungs...
- Hyperviscosity syndromeHyperviscosity syndromeHyperviscosity syndrome is a group of symptoms triggered by increase in the viscosity of the blood. Symptoms of high blood viscosity include spontaneous bleeding from mucous membranes, visual disturbances due to retinopathy, and neurologic symptoms ranging from headache and vertigo to seizures and...
s:- CryoglobulinemiaCryoglobulinemiaCryoglobulinemia is a medical condition in which the blood contains large amounts of cryoglobulins - proteins that become insoluble at reduced temperatures. Cryoglobulins typically precipitate at temperatures below normal body temperature and will dissolve again if the blood is heated...
- ParaproteinemiaParaproteinemiaParaproteinemia, or monoclonal gammopathy, is the presence of excessive amounts of a single monoclonal gammaglobulin in the blood...
- Waldenström macroglobulinemiaWaldenström macroglobulinemiaWaldenström's macroglobulinemia is cancer involving a subtype of white blood cells called lymphocytes. The main attributing antibody is Immunoglobulin M . WM is an "indolent lymphoma,"...
- Cryoglobulinemia
- Myasthenia gravisMyasthenia gravisMyasthenia gravis is an autoimmune neuromuscular disease leading to fluctuating muscle weakness and fatiguability...
- Thrombotic thrombocytopenic purpuraThrombotic thrombocytopenic purpuraThrombotic thrombocytopenic purpura is a rare disorder of the blood-coagulation system, causing extensive microscopic thromboses to form in small blood vessels throughout the body...
(TTP)/hemolytic uremic syndrome - Wegener's granulomatosisWegener's granulomatosisWegener's granulomatosis , more recently granulomatosis with polyangiitis , is an incurable form of vasculitis that affects the nose, lungs, kidneys and other organs. Due to its end-organ damage, it is life-threatening and requires long-term immunosuppression...
- Lambert-Eaton Syndrome
- Antiphospholipid Antibody Syndrome (APS or APLS)
- Microscopic polyangiitisMicroscopic polyangiitisMicroscopic polyangiitis is an ill-defined autoimmune disease characterized by pauci-immune, necrotizing, small-vessel vasculitis without clinical or pathological evidence of necrotizing granulomatous inflammation.-Presentation:Because many different organ systems may be involved, a wide range of...
- Recurrent focal and segmental glomerulosclerosis in the transplanted kidneyFocal segmental glomerulosclerosisFocal segmental glomerulosclerosis is a cause of nephrotic syndrome in children and adolescents, as well as an important cause of kidney failure in adults.It is also known as "focal glomerular sclerosis" or "focal nodular glomerulosclerosis"....
- HELLP syndromeHELLP syndromeHELLP syndrome is a life-threatening obstetric complication usually considered to be a variant of pre-eclampsia. Both conditions usually occur during the later stages of pregnancy, or sometimes after childbirth.HELLP is an abbreviation of the main findings:...
- PANDAS syndrome
- Refsum disease
- Behcet syndrome
- HIVHIVHuman immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
-related neuropathy - Graves' diseaseGraves' diseaseGraves' disease is an autoimmune disease where the thyroid is overactive, producing an excessive amount of thyroid hormones...
in infants and neonates - Pemphigus vulgarisPemphigus vulgarisPemphigus vulgaris is a chronic blistering skin disease with skin lesions that are rarely pruritic, but which are often painful.-Pathophysiology:...
- Multiple sclerosisMultiple sclerosisMultiple sclerosis is an inflammatory disease in which the fatty myelin sheaths around the axons of the brain and spinal cord are damaged, leading to demyelination and scarring as well as a broad spectrum of signs and symptoms...
- RhabdomyolysisRhabdomyolysisRhabdomyolysis is a condition in which damaged skeletal muscle tissue breaks down rapidly. Breakdown products of damaged muscle cells are released into the bloodstream; some of these, such as the protein myoglobin, are harmful to the kidneys and may lead to kidney failure...
Complications of plasmapheresis therapy
Though plasmapheresis is helpful in certain medical conditions, like any other therapy, there are potential risks and complications. Insertion of a rather large intravenous catheter can lead to bleeding, lung puncture (depending on the site of catheter insertion), and, if the catheter is left in too long, it can get infected.Aside from placing the catheter, the procedure itself has complications. When patient blood is outside of the body passing through the plasmapheresis machine, the blood has a tendency to clot. To reduce this tendency, in one common protocol, citrate
Citrate
A citrate can refer either to the conjugate base of citric acid, , or to the esters of citric acid. An example of the former, a salt is trisodium citrate; an ester is triethyl citrate.-Other citric acid ions:...
is infused while the blood is running through the circuit. Citrate binds to calcium
Calcium
Calcium is the chemical element with the symbol Ca and atomic number 20. It has an atomic mass of 40.078 amu. Calcium is a soft gray alkaline earth metal, and is the fifth-most-abundant element by mass in the Earth's crust...
in the blood, calcium being essential for blood to clot. Citrate is very effective in preventing blood from clotting; however, its use can lead to life-threateningly low calcium levels. This can be detected using the Chvostek's sign or Trousseau's sign. To prevent this complication, calcium is infused intravenously while the patient is undergoing the plasmapheresis; in addition, calcium supplementation by mouth may also be given.
Other complications include:
- Hypotension
- Potential exposure to blood products, with risk of transfusion reactions or transfusion transmitted diseases
- Suppression of the patient's immune systemImmune systemAn immune system is a system of biological structures and processes within an organism that protects against disease by identifying and killing pathogens and tumor cells. It detects a wide variety of agents, from viruses to parasitic worms, and needs to distinguish them from the organism's own...
- Bleeding or hematomaHematomaA hematoma, or haematoma, is a localized collection of blood outside the blood vessels, usually in liquid form within the tissue. This distinguishes it from an ecchymosis, which is the spread of blood under the skin in a thin layer, commonly called a bruise...
from needle placement
As a manufacturing process
Donating plasma is similar in many ways to whole blood donationBlood donation
A blood donation occurs when a person voluntarily has blood drawn and used for transfusions or made into medications by a process called fractionation....
, though the end product is used for different purposes. Most plasmapheresis is for fractionation
Fractionation
See also: Fractionated spacecraftFractionation is a separation process in which a certain quantity of a mixture is divided up in a number of smaller quantities in which the composition changes according to a gradient. Fractions are collected based on differences in a specific property of the...
into other products; other blood donations are transfused with relatively minor modifications. Plasma that is collected solely for further manufacturing is called Source Plasma.
Plasma donors undergo a screening process to ensure both the donor's safety and the safety of the collected product. Factors monitored include blood pressure
Blood pressure
Blood pressure is the pressure exerted by circulating blood upon the walls of blood vessels, and is one of the principal vital signs. When used without further specification, "blood pressure" usually refers to the arterial pressure of the systemic circulation. During each heartbeat, BP varies...
, pulse
Pulse
In medicine, one's pulse represents the tactile arterial palpation of the heartbeat by trained fingertips. The pulse may be palpated in any place that allows an artery to be compressed against a bone, such as at the neck , at the wrist , behind the knee , on the inside of the elbow , and near the...
, temperature, total protein, protein electrophoresis
Protein electrophoresis
Protein electrophoresis is a method for analysing the proteins in a fluid or an extract. The electrophoresis may be performed with a small volume of sample in a number of alternative ways with or without a supporting medium: SDS polyacrylamide gel electrophoresis Protein electrophoresis is a method...
, health history screening similar to that for whole blood
Blood donation
A blood donation occurs when a person voluntarily has blood drawn and used for transfusions or made into medications by a process called fractionation....
, as well as an annual physical exam with a licensed physician or an approved physician substitute under the supervision of the physician. Donors are screened at each donation for viral diseases that can be transmitted by blood, sometimes by multiple methods. For example, donors are tested for HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
by ELISA
ELISA
Enzyme-linked immunosorbent assay , is a popular format of a "wet-lab" type analytic biochemistry assay that uses one sub-type of heterogeneous, solid-phase enzyme immunoassay to detect the presence of a substance in a liquid sample."Wet lab" analytic biochemistry assays involves detection of an...
, which will show if they have ever been exposed to the disease, as well as by nucleic acid methods (PCR or similar) to rule out recent infections that might be missed by the ELISA test. Industry standards require at least two sets of negative test results before the collected plasma is used for injectable products. The plasma is also treated in processing multiple times to inactivate any virus that was undetected during the screening process.
Plasma donors are typically paid cash for their donations, though this is not universal. For example, donors in the UK, Australia and New Zealand are not given financial incentives. Since the products are heavily processed and treated to remove infectious agents, the higher risk is considered acceptable. Standards for donating plasma are set by national regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Union, and by a professional organization, the Plasma Protein Therapeutics Association (or PPTA), which audits and accredits collection facilities. A National Donor Deferral Registry (NDDR) is also maintained by the PPTA for use in keeping donors with prior positive test results from donating at any facility.
Almost all plasmapheresis in the US is performed by automated methods such as the Plasma Collection System (PCS2) made by Haemonetics
Haemonetics
Haemonetics is a global provider of blood and plasma supplies and services. Founded in Braintree, Massachusetts by Dr. Jack Latham in the 1970s, the company has expanded and has many offices located in 16 countries....
or the Autopheresis-C (Auto-C) made by Fenwal, a division of Baxter International
Baxter International
Baxter International Inc. , is an American health care company with headquarters in Deerfield, Illinois. The company primarily focuses on products to treat hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions...
. In some cases, automated plasmapheresis is used to collect plasma products like Fresh frozen plasma
Fresh frozen plasma
The term fresh frozen plasma refers to the liquid portion of human blood that has been frozen and preserved after a blood donation and will be used for blood transfusion...
for direct transfusion purposes, often at the same time as plateletpheresis
Plateletpheresis
Plateletpheresis is the process of collecting thrombocytes, more commonly called platelets, a component of blood involved in blood clotting...
.
Manual method: For the manual method, approximately the same as a whole blood donation
Blood donation
A blood donation occurs when a person voluntarily has blood drawn and used for transfusions or made into medications by a process called fractionation....
is collected from the donor. The collected blood is then separated by centrifuge machines in separate rooms, the plasma is pressed out of the collection set into a satellite container, and the red blood cells are returned to the donor. Since returning red cells causes the plasma to be replaced more rapidly by the body, a donor can provide up to a liter of plasma at a time and can donate with only a few days between donations, unlike the 56-day deferral for blood donation. The amount allowed in a donation varies vastly from country to country, but generally does not exceed two donations, each as much as a liter, per 7-day period.
The danger with this method was that if the wrong red blood cells were returned to the donor, a serious and potentially fatal transfusion reaction could occur. Requiring donors to recite their names and ID numbers on returned bags of red cells minimized this risk. This procedure has largely become obsolete in favor of the automated method.
Automated method: The automated method uses a very similar process. The difference is that the collection, separation, and return are all performed inside a machine which is connected to the donor through a needle placed in the arm, typically the antecubital vein. There is no risk of receiving the wrong red cells. The devices used are very similar to the devices used for therapeutic plasmapheresis, and the potential for citrate toxicity is similar. The potential risks are explained to prospective donors at the first donation, and most donors tolerate the procedure well.
If a significant amount of red blood cells cannot be returned, the donor may not donate for 56 days, just as if they had donated a unit of blood. Depending on the collection system and the operation, the removed plasma may be replaced by saline
Saline
Saline may refer to:* Salinity, the salt content of a solution** Saline water, water containing significant concentration of salts* Soil salinity, salt content of soil* Saline , a liquid with salt content to match the human body...
. The body will typically replace the collected volume within 24 hours, and donors typically donate up to twice a week, though this varies by country.
The collected plasma is promptly frozen at lower than -20 °C (-4 °F) and is typically shipped to a processing facility for fractionation. This process separates the collected plasma into specific components, such as albumin
Albumin
Albumin refers generally to any protein that is water soluble, which is moderately soluble in concentrated salt solutions, and experiences heat denaturation. They are commonly found in blood plasma, and are unique to other blood proteins in that they are not glycosylated...
and immunoglobulins, most of which are made into medications for human use. Sometimes the plasma is thawed and transfused as Fresh Frozen Plasma (FFP), much like the plasma from a normal blood donation.
Donors are sometimes immunized against agents such as tetanus
Tetanus
Tetanus is a medical condition characterized by a prolonged contraction of skeletal muscle fibers. The primary symptoms are caused by tetanospasmin, a neurotoxin produced by the Gram-positive, rod-shaped, obligate anaerobic bacterium Clostridium tetani...
or hepatitis B so that their plasma contains the antibodies against the toxin or disease. In other donors, an intentionally incompatible unit of blood is transfused to produce antibodies to the antigens on the red cells. The collected plasma then contains these components, which are used in manufacturing of medications. Donors who are already ill may have their plasma collected for use as a positive control for laboratory testing.