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Indian Journal of Transfusion Medicine
  Indian Journal of Transfusion Medicine Indian Journal of Transfusion Medicine

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Plasma By Apheresis

                                                                                                        Dr. Rajesh Deshpande

                                                                                                                                                                     MD (Pathology) 

The field of Transfusion Medicine has shown tremendous   progress in the past few years worldwide. There is an increasing awareness on the risks of the transfusion transmitted diseases and a growing concern regarding  blood safety. 

Today, it has become the critical responsibility of the blood banking fraternity to adopt methods and processes  that will provide high quality, disease-free safe blood to  patients. 

In this direction, advanced technology has led to the advent of automated blood cell collection and separation, which can provide blood components with consistent high yield & high purity. 

Automation ensures optimal utilization of the available donor resources, thereby increasing the blood center’s inventory through fewer donors and providing tailor-made therapeutic doses of components through programmable protocols. 

Automated Blood cell separation involves the use of equipment, The Blood Cell Separator, which collects an optimal amount of a desired blood component in a short collection time from a single eligible donor. Only  the required component is retained in the disposable  set of the machine, returning the remaining blood back  to him. The amount of component to be collected is  programmable depending on the  equirement. The  product collected is of high yield and purity with minimal  leukocyte contamination. This process of selective   component collection is known as APHERESIS. 

Apheresis helps to maximize the utilization of the  available donor resources, since multi-dose and multicomponent  collections can be achieved from a single  donor. As a result, multiple donor exposure as well as the risk of disease transmission is significantly reduced. Besides collecting high dose and high quality components from a donor, apheresis technology is also used for therapeutic removal of diseases or unwanted products from the patient. 

Any of the blood components can be collected using    Apheresis. Thus, various apheresis procedures are in use – Plateletpheresis, Leucopheresis, Plasmapheresis and Erythrocytopheresis.

Collection of Plasma from healthy donors is known  as Plasmapheresis. During this process, a desired volume of cell-free plasma is collected from a donor  with return of all the cellular components. The  collected plasma is free of both platelets and white blood cells, besides the red cells. 

Donor Plasmapheresis is not synonymous to  Therapeutic Plasma Exchange procedure, which involves the therapeutic removal of diseased plasma from patients with simultaneous replacement with normal plasma or comparable fluids. 

Plasmapheresis began way back in 1914, as a manual procedure for therapeutic purpose. Initially it was done manually by removing whole blood in a blood bag. The blood bag was then centrifuged and the supernatant plasma was removed. The remaining cells were reinfused back. This, however, was laborious and had limitations.

It was only the introduction of automated equipments or cell separators that led to a wider acceptance of apheresis technology. 

Automated Plasmapheresis: 

The advent of automation helped to collect 2-3 units  of Plasma from a single donor, as against one unit prepared from a whole blood collection, thereby  reducing donor exposure. 

Automated Plasmapheresis is based on the  principle of separation of plasma by centrifugation  and /or membrane filtration. Herein, the whole blood of the donor is centrifuged inside the machine and separated into plasma and cells. Membrane filtration also helps to separate the cells from Plasma. The plasma is retained inside the  disposable kit used on the machine and the cells  are returned back to the donor. 

Various apheresis machines from established healthcare  companies are available in the market for performing Plasmapheresis. Among these, Autopheresis-C from Fenwal and PCS from Hemonetics are machines exclusively introduced for collecting only plasma. Each machine utilizes a one-time use, sterile disposable kit comprising of tubings and containers for the procedure and this kit is unique for every machine. The kit has a fixed pathway for the donor’s blood and ensures that the blood does not come in contact  with the machine. The machines have sensors and detector to minimize cellular contamination 

Autopheresis-C is a microprocessor controlled device which  works on the combined principle of  entrifugation (rotation) and membrane filtration. The disposable set of the Auto-C has a separation device called the Plasmacell-C, which consists of a rotor and a spinning membrane. During the procedure, blood entering the device separates into cells and plasma due to the rotation of the membrane. Thus there is separation as well as membrane filtration, resulting in a cellfree product. This is a single arm procedure comprising of a draw cycle and a return cycle. The blood enters the separation device and separated during the draw cycle. The separated red cells are returned back to the donor during the return cycle. Cycles continue until the desired plasma volume is attained. About 600 ml of cell-free plasma is collected in 35 m i n u t e s . 

Advantages of Automated Plasmapheresis: 

  • Donor safety through Single arm access, Short   procedure time and Low extracorporeal volume 
  • Automated monitoring and on-line processing reduces manual errors 
  • Patient safety through :Limited donor exposure, beneficial effects of leukodepletion and Reduced incidence of TTD/ transfusion reactions 
  • Automation facilitates large volume collection which helps in providing the optimal dose. 
  • Benefits for the blood center include Ease of operation due to complete automation, donor retention due to a fast & Safe process and
  • Low procedure costs due to reduced labor, increased  donor throughput and high yields 
  • The plasmapheresis procedure is performed on healthy donors and is normally well tolerated. The common adverse effects include Citrate toxicity, Syncope or rarely, hypovolemia. Albumin levels of frequent donors have to be monitored. 

Indications of Donor Plasmapheresis: 

Plasmapheresis is essentially performed 

To collect plasma for transfusion as FFP or 

To source Plasma for further manufacturing. 

Collection of plasma by apheresis is an optimal way to build   up the inventory of Fresh Frozen Plasma. As mentioned above, 2-3 units of Plasma (Jumbo unit) are collected from a single donor within a span of half an hour in contrast to the one unit  prepared from a whole blood collection. The amount of plasma available from a single whole blood collection for FFP preparation is in the range of 150-200ml (depending on the collection volume 350 or 450ml). Normally, a patient’s requirement is at least 2-3 units of FFP. Hence, an apheresis procedure leading a collection of 500ml plasma  will provide the necessary therapeutic dose from one donor itself. 

The jumbo FFP units available from Plasmapheresis can be primarily used for the following: 

Treatment of patients requiring multiple units of FFP- Massive  Blood loss, Bleeding, Coagulation Factor deficiencies   Replacement fluid in Therapeutic Plasma Exchange  Patient specific plasma such as plasma from IgA negative donors for transfusion 

Thus, the major advantage of the process is Maximization of   available Donor Resources and Reduced donor exposure for the Patient. 

The other major indication of Plasmapheresis is making   source plasma available for fractionation and preparation of various plasma products. 

Plasma collected by apheresis can be used for: 

Plasma Fractionation to prepare Albumin, IVIG and Fibrin  glue 

Preparation of various immunoglobulins such as Rh, Tetanus etc. 

Preparation of coagulation factors – factor VIII and IX  Many countries such as US, Europe, Korea have plasma  fractionation plants that require large amounts of plasma for  manufacturing the plasma products. As a result, they have multiple plasma collection centers with Plasmapheresis   equipments. Voluntary plasma donors visit these centers regularly to donate their plasma. 

Guidelines for Plasmapheresis (as per the NACO standards):

Selection of donors: 

In an occasional plasmapheresis, in which donors undergo  the process once every 12 weeks the standard criteria for  whole blood donation should apply. 

In a ‘serial’ plasmapheresis in which plasma is donated more frequently than once every 12 weeks, the donor should be  tested before every pheresis procedure - Hemoglobin and/or hematocrit should be > 12 g/dl and/or Hct 36% - Total serum  protein - should not be below 6.0 gm/dl 

In serial plasmapheresis programme with return of the cellular 

components a minimum interval should be of 48 hours between   two procedures and not more than two procedures in a week  should be allowed. 

If a participant of such programme donates a unit of blood or if  it is not possible to return red cells, the donor should not   undergo platelet /plasmapheresis for 12 weeks. 

Volume of Plasma: Volume of plasma obtained excluding   anticoagulants from a donor weighing at least 55 kgs should  not exceed 500 ml with serum protein within normal limit during one procedure or not more than 1000 ml per month with a maximum of 12 L / year. Extra corporeal blood volume shouldnot exceed 15% of donor’s estimated blood volume. Thus, Plasmapheresis is a safe, efficient and fast procedure to collect optimal doses of plasma through automation ensuring donor safety and comfort and potential patient benefits.

 

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Dr. RAJESH DESHPANDE
MD (PATHOLOGY)
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