Products / Services

Plasma derived products

There are wide ranges of plasma products available with specific indications for their use. All plasma products utilise liquid or frozen plasma as their starting material. This may then be subjected to simple physical or more complex chemico-physical processing to produce specific products; the latter are termed plasma derivatives.

The various products, usage guidelines, and recommended dosage schedules are outlined below. Clinicians should be aware that all these products are antigenic and are potentially capable of causing allergic or anaphylactic reactions. The patient should be observed as for cellular products during the initial 15 minutes of any transfusion.

Fresh Frozen Plasma

Fresh frozen plasma is separated from anticoagulated whole blood within 18 hours of donation. This is done by separating the plasma in a closed sterile system and freezing it to below -18 °C. It contains all the clotting factors in normal physiological levels. Fresh frozen single donor plasma carries the same risk of latent viral infection as a unit of red cell concentrate. However, a lyophilised fresh plasma product (Bioplasma FDP), aliquoted from large pools of plasma and treated with a solvent-detergent preparation to inactivate undetected lipoprotein coated viruses is available from National Bioproducts Institute in 50 ml and 200 ml volumes when reconstituted. Other areas, at the time of writing, are introducing retested quarantined FFP as an alternative method of avoiding window period infections. Indications and dosages for both products are similar.

FFP must be thawed before use according to the instructions detailed on the package, or by the hospital blood bank before issue. In the case of FDP reconstitute according to the guidelines provided by the manufacturer.

Notes:

Units of FFP must be administered through a blood giving set after thawing at 30-37 oC. Compatibility testing is not required but units should be ABO compatible with the patient's red cells, especially if large volumes are to be transfused. If the ABO group of the patient is not available then group AB fresh frozen plasma should be used as it contains no A or B isoagglutinins.

Transfuse as rapidly as possible, at 15-20 minutes per unit in the average adult in order to obtain a good clinical effect. The labile coagulation factors deteriorate within a few hours of thawing or reconstitution.

Specific Coagulation Factor Products

All these products are produced from fresh frozen plasma and are used in a variety of bleeding disorders when one or other of the coagulation factors is deficient.

Dosage Schedule

The levels of Factor VIII or other relevant factor should be monitored throughout therapy. This facility may not be available in areas away from major treatment centres and dosage schedules may have to be empirically applied therefore as suggested below. However, elective major surgery in haemophiliacs and treatment of major haemorrhage should be undertaken only at centres where access to proper monitoring is available. Contact your local haematologist or haemophilia treatment centre for help.

Factor VIII has a half-life of 8-12 hours so treatment should be given every 8-12 hours for at least the first 24 hours and then every 12 hours. After major surgery the transfusions may be required on a scheduled basis for at least 10 days. Following transfusion of Factor VIII there is a more prolonged rise in Factor VIII in patients with vWD; therefore transfusions of concentrate for vWD are usually required only every 24 hours.

Haemophilia A

When haematological monitoring is available the number of Factor VIII units required may be calculated from the following formula:

Note:
All elective surgery should be undertaken in a specialist centre.Transfusion of factor should be rapid. Patients should be observed carefully for any untoward reaction to the product, particularly those of allergic nature. See Reactions "Allergic/Anaphylactic" (Section 11).
When monitoring is available (recommended for all major operations) more exact regimens can be followed. Continuous transfusion regimens are also efficacious and may well provide more consistent haemostatis levels. These regimens should, however, be under specialist supervision.

It should be borne in mind that about 10% of Haemophilia A patients have antibodies (inhibitors) to Factor VIII and these patients may not respond to the therapy described above. These patients must be referred to a specialist haemophilia treatment centre as an emergency.

Von Willebrand Disease (VWD)

Intermediate purity Factor VIII concentrates are the treatment of choice where DDAVP (vasopressin analogue) is not effective. The local products contain adequate amounts of high molecular weight multimers.

Dosage

• Use Factor VIII units as a measurable entity.
• Using 30 iu units of Factor VIII per kg.
• Monitor every 24 hours.
• If bleeding persists despite adequate levels of Factor VIII, then transfuse Cryoprecipitate (10-20 iu units FVIII per kg) or Random platelet concentrate (1 concentrate per 10 kg).

Haemophilia B

The clinical picture of Haemophilia B is identical to that of Haemophilia A, and the levels required are similar to those of Haemophilia A, although slightly lower levels of Factor IX are usually adequate for normal haemostasis. Factor IX has a longer half-life than Factor VIII (up to 24 hours) and therefore only daily doses may be required. For prolonged therapy (> 5 days) a pure Factor IX concentrate is preferable since prolonged Factor IX complex transfusion has been reported to lead to thrombosis. The reports however only refer to concentrates manufactured outside South Africa. There have been no reports of thrombosis with the local product. When haematological monitoring is available the number of Factor IX units required may be calculated from the following formula:

If monitoring is not available, give 10-20 iu/kg as a daily or twice daily dose regime. Do not give in conjunction with Cyclokapron® or Amicar®.

Hypofibrinogenaemia

Other Plasma Products

Albumin 20% Solution

Prepared by fractionation of a large pool of plasma. The process involves steps like pasteurisation and cold ethanol fractionation, which inactivates viruses such as HIV and hepatitis virus.

Practical Note:

Volume expansion in acute hypovolaemia is more appropriately obtained using crystalloid or synthetic colloid solutions.

In a dehydrated patient it is inappropriate to use 20% Albumin solution as a volume expander. If a physiological albumin solution is required then add 100 ml 20% albumin to 400 ml saline or Ringers lactate. There is a 4% product available from NBI.

In thermal burns the early restoration of fluid volume is best achieved with crystalloids. Albumin may be given 8-12 hours after the onset of the burn

Dosage:

• Calculate the patient's plasma volume from the following formula
• Calculate the number of grams of albumin required for a particular patient as follows:
  

Since half the albumin transfused will diffuse into the extravascular compartment it is necessary to use this multiplication factor to achieve the desired intravascular levels.

Products available

• 4% Albumin in 8 g/200 ml and 16 g/400 ml bottles (NBI).
• 20% albumin in 20 g/100 ml, 10 g/50 ml bottles (WPBTS, NBI).

Note:
Assess carefully before administering to any patient with known hypersensitivity to human proteins.

Stabilised Human Serum

Stabilised Human Serum is prepared from large pools of donor plasma that is subjected to:

• Selective absorption of lipoprotein, coagulation factors, and complement components.
• Reduction of viral content by the above processes and by ultra violet irradiation.
• A heat treatment step that is licensed as a validated viral inactivation procedure for HIV.
• The resultant stable protein solution contains a wide and constant spectrum of antibodies in the IgA, IgM and IgG classes, many of the transport proteins, and albumin. It provides an ideal physiological volume expander in a volume equivalent to that lost.

Usage

• Burns.
• Hypovolaemia.

Administration

• Adults: Intravenous transfusion to a dosage of up to 8 units of 250 ml per 24 hours.
• Children: 3-6 ml per kg per 24 hours.

Side effects

• Transient urticarial reactions.
• Pyrexia.
• Rigors.
• Hypotension.

Treatment of side effects

Stop transfusion, and administer antihistamines, prednisone, or hydrocortisone either intramuscularly, or intravenously, depending on the severity of the symptoms.

Important:

Do not give to any patient with a known sensitivity or allergy to human protein solutions.

Immunoglobulin Therapy

Immunoglobulin is the antibody-containing fraction of human plasma that is obtained by the fractionation of pooled plasma units, all of which have been tested and found non-reactive for HBsAg, anti-HCV, anti-HIV and p24 HIV antigen. Specific hyperimmune immunoglobulin preparations are prepared from plasma from donors with high titres of specific antibodies. The manufacturing process per se for immunoglobulins has virucidal effects and preparations used and manufactured in South Africa have never been reported to transmit hepatitis or HIV. More recently introduced intravenous products contain specific viral inactivation steps for lipid enveloped viruses.

Practical Note:

Anaphylactic reactions may occur if an intramuscular product is used intravenously.
Anaphylactic or severe allergic reactions may occur if the patient suffers from IgA deficiency, or has experienced a previous severe reaction to human protein product.

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