Frequently Asked Questions
General Information
What is plasmapheresis?
Who donates plasma?
What type of medical screening and testing is done?
How often can plasma be donated?
How long does it take to donate plasma?
How is the plasma removed?
How much plasma is needed?
Can I get AIDS from donating plasma?
What compensation do plasma donors receive?
What products are made from plasma and what are their uses?
General Information
Q: What is plasmapheresis?
A:
Plasmapheresis is the process of removing whole blood and separating red blood cells from plasma using a specialized, sterile piece of medical equipment. The red blood cells are then returned to the donor and the plasma is retained for use in producing medical therapies.
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Q: Who donates plasma?
A:
Anyone at least 18 years of age and who weighs at least 110 pounds (in Europe, the weight limit is at least 50 kg) can donate plasma. All individuals who donate plasma must pass a brief medical examination, extensive medical history screening, and testing for transmissible viruses.
Contact a donation center near you to learn about any state-or country-specific guidelines.
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Q: What type of medical screening and testing is done?
A:
In order to ensure the safety of the donor and of the final therapies, significant testing and medical screening is conducted of source plasma donors. Most countries in the U.S. and Western Europe require all plasma donors to have a pre-donation physical, including medical history questions, tests for syphilis (not required in all EU countries), hepatitis, and human immunodeficiency virus (HIV), total plasma protein and hematocrit/hemoglobin levels, and urinalysis (not necessarily done in all EU centers). Industry's International Quality Plasma Program (IQPP) requires additional donor screening, such as drug abuse testing and donor education on high-risk behavior and residency requirements. IQPP standards are not necessarily introduced in all EU member centers.
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Q: How often can plasma be donated?
A:
The body replaces the donated plasma usually within 24 to 48 hours if the donor keeps a healthy diet with an adequate amount of fluids and proteins. Individual countries have differing policies on donation frequencies. In the United States, a person may donate two times in every seven days, with at least two days in between. In Europe the Council of Europe's guidelines specify the volumes which can be donated on each occasion and how often the donor can give blood or plasma. In absence of volume replacement not more than 600 ml net volume of plasma should be removed. According to the guidelines, plasma collection should not take place more often than every second week. No more than 15 liters of plasma per year should be collected from an individual donor. However, these recommendations are given for the collection of plasma for therapeutic use. For plasma for fractionation, the Council of Europe sets no limitations.
Individual countries have different policies on donation frequencies and volumes. In Germany, the maximum volume which can be given in one year is 25 liters, whereas in Austria the limit is 50 donations per year corresponding to approximately 35 liters. In Austria the maximum frequency of donation is three times per two weeks. In Sweden, a maximum of 15 liters of plasma (anticoagulant excluded) can be collected per year, and a maximum of 550 ml of plasma can be collected per session. For blood donors weighing more than 80 kg, the latter volume can be increased to 600 ml.
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Q: How long does it take to donate plasma?
A:
To ensure that the donor meets the medical health screening and testing requirements, the first visit takes about two to three hours. Subsequent visits take about one and a half hours.
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Q: How is the plasma removed?
A:
Donating plasma is similar to donating blood. A needle is placed in the vein of an arm and blood is collected in specialized medical equipment called a plasmapheresis device. The plasma is separated from the red blood cells and other cellular components of the blood. The red blood cells are returned to the donor often with sterile saline solution to help the body replace the plasma removed from the blood. Any and all material that comes into dontact with the donor's blood during plasmpheresis is sterile and single-use.
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Q: How much plasma is needed?
A:
Worldwide, the total demand for plasma by fractionators (pharmaceutical companies who further manufacture human plasma into plasma- derived therapies) exceeds 20 million liters. The amount collected by plasmapheresis in source plasma collection facilities is roughly 13 million liters from more than 15 million donations. The remaining liters are recovered from whole blood donations at community or Red Cross blood banks.
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Q: Can I get AIDS from donating plasma?
A:
No. Plasma donations are made in a highly controlled, sterile environment by professionally trained staff. All plasma collection equipment is sterilized and equipment that gets in contact with the donor's blood or plasma is used only once, eliminating the possibility of transmitting any viral infection.
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Q: What compensation do plasma donors receive?
A:
To guarantee a safe and adequate supply of donors, the industry developed a system of donor compensation which recognizes the substantial commitment of personal time and effort required from donors. Current automated plasmapheresis (the method used to collect source plasma) donation systems and manufacturing supply requirements often demand that donors visit a collection center up to twice per week for one-and-a-half to two hours each visit. Each collection center sets its own compensation.
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Q: What products are made from plasma and what are their uses?
A:
Hundreds of different proteins have been found in human plasma. The function of many of these are unknown, and many are present in very small quantities. The plasma protein therapeutics industry is able to separate out a number of these proteins from which they can make a range of life-saving medicines:
Albumin
One of the first human proteins to be used clinically was albumin. It was developed as a stable human plasma substitute in World War II. Today, albumin is widely used in the treatment of shock, burns, adult respiratory distress syndrome and during cardiopulmonary bypass surgery. Human albumin replacement can speed recovery and increase survival in critical care patients. Albumin restores circulating blood volume where volume deficiency has been demonstrated.
Alpha 1 Proteinase Inhibitor
Alpha-1 antitrypsin is a protein found in the lungs that prevents them from being broken down by the body's natural enzymes. An inherited disorder (Alpha-1 Antitrypsin Deficiency) can lead to damage in the lungs (emphysema) and in the liver, and administration of this therapy prevents further damage from occuring in the lungs.
Coagulation (Clotting) Factors
Factors VIII and IX and von Willebrand Factor (VWF) are the major medicines that help those born with disorders of their blood clotting system (e.g. hemophilia). A fibrin sealant is also used to aid clotting and to close wounds during surgery.
Immunoglobulins
A healthy immune system is vital to a normal life. Unfortunately, some of us cannot make our own protective antibodies and depend on supplementary infusions of immunoglobulins. This may be because they are born with an inherited condition or because another illness, such as leukemia, prevents them from making antibodies. In these cases, it is necessary to provide a broad spectrum of antibodies from donated plasma. Others may develop harmful antibodies which attack their own tissues. Immunoglobulins help to modify this autoimmune reaction and prevent progression of the disorder.
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