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Plasma products
General information
Plasma products are used to substitute plasma proteins and in plasma exchange. Fresh frozen plasma is used as a source of coagulation factors in deficiency, if no purified factors are available.
Intensive plasma exchange has been studied in the treatment of numerous diseases, above all in Waldenström’s macroglobulinemia, hypercholesterolemia, hyperviscosity syndrome, thrombotic thrombocytopenic purpura, systemic lupus erythematosus, myasthenia gravis, hemolytic–uremic syndrome, Goodpasture’s syndrome, Guillain–Barré syndrome, and several other autoimmune diseases. Its potential benefit is attributable to the removal of a variety of harmful substances from plasma, such as antibodies, antigens, immune complexes, toxins, or abnormal plasma components. If the circulating substance is a cause of the disease, the plasma exchange can be effective. However, its therapeutic potential in many diseases has not been precisely defined.
The performance of intensive plasma exchange (removal from an adult of 2–3 liters of plasma with substitution of fresh plasma to maintain the patient’s blood volume) requires separation of plasma from cells, so that the patient’s own cells can be returned. There are two methods of plasma separation: centrifugal flow separation and flow filtration [ , ].
Only a few serious complications of intensive plasma exchange have been reported. The potential complications [ ] include transient hypotension, nausea, urticaria, abdominal discomfort, fever, hypothermia, air or microaggregate embolism, hypocalcemia (citrate effect) with paresthesia and tetany, thrombocytopenia, coagulation factor depletion and depletion of various intravascular proteins, visual scotomata, hepatitis, vasovagal reactions, and reactions associated with phlebotomy (phlebitis, hematoma).
The fluid volume and protein removed by plasmapheresis must be replaced. Among the solutions available for replacement therapy are fresh frozen plasma and human albumin solutions.
Antithrombin III
Antithrombin III is promising in mild or severe veno-occlusive disease. In a retrospective series of 48 patients directed at early intervention rather than prophylactic therapy to correct the antithrombin deficiency associated with veno-occlusive disease, there was no treatment-related morbidity; specifically, there were no overt complications such as bleeding or thrombosis [ ]. In critically ill patients, a systematic review of 20 clinical trials in 3458 patients who were given antithrombin III, placebo, or no treatment showed that antithrombin III was ineffective in reducing overall mortality, but increased the risk of bleeding events [ , ].
C1 inhibitor concentrate
Hereditary angioedema, which is effectively and safely treatable with C1 esterase inhibitor concentrates, continues to constitute a significant burden of disease to those affected even in the industrialized world. Other therapeutic indications for C1 esterase inhibitor concentrates relating to inflammatory disease other than are currently being studied, including post-ischemic myocardial protection, capillary leak syndrome, and sepsis [ , ]. The main adverse reactions to C1 esterase inhibitor concentrate, although very rare, are allergic reactions. In a study of the beneficial effects of C1 esterase inhibitor concentrates in ST-elevation myocardial infarction in patients undergoing surgical reperfusion, no adverse events were reported [ ].
Fresh frozen plasma
Fresh frozen plasma is defined as the fluid portion of 1 unit of human blood that has been centrifuged and separated and then frozen at − 18 °C (or below) within 6 hours of collection. It is used to reverse the effects of oral anticoagulants (for example during surgery or bleeding episodes) [ ]. Its use has increased considerably in most countries within the past 20–25 years [ ], in spite of mounting evidence of its potential risks, such as the transmission of viral infections. Allo-immunization occurs infrequently, with the formation of Rh antibodies in response to contaminating stroma of red blood cells, and as with any intravenous administered fluid, hypervolemia and cardiac failure can occur [ ]. Anti-A and anti-B in the plasma can hemolyse the recipient’s red cells if ABO-compatible fresh frozen plasma is not used [ ]. Other disadvantages of fresh frozen plasma are the large volume that needs to be given, the risk of viral transmission, and the variable quantities of clotting factors it contains. Quarantine fresh frozen plasma, when the unit is used after the next consecutive donation of the same donor has been found to be negative in virus screening assays, is a safe alternative.
Drug studies
Systematic reviews
Assessment of the evidence for the use of fresh frozen plasma, showed 57 identified published trials, most of which enrolled small numbers of patients, resulting in inadequate information on outcomes. Moreover, adverse reactions might annul clinical benefits, and new trials therefore need to be conducted to determine the effectiveness of fresh frozen plasma [ ].
Organs and systems
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