Document 0394
 DOCN  M9550394
 TI    Safety of plasma derivatives.
 DT    9505
 AU    Ingerslev J; Department of Clinical Immunology, University Hospital,;
       Aarhus/Skejby, Denmark.
 SO    Haemostasis. 1994 Sep-Oct;24(5):311-23. Unique Identifier : AIDSLINE
       MED/95145974
 AB    In clinical treatment practice of substitution therapy involving a
       plasma component, numerous aspects related to recipient's safety are
       relevant to the physician. Since viral contaminants may be present in
       the donor blood, safety begins in the institution collecting raw plasma
       where donors are inquired about any unusual behavior that may
       potentially threaten safety. Other measures that could lead to exclusion
       of a donation are positive serological tests for HIV and hepatitis B and
       C. In this context, meticulously accurate logistics are mandatory.
       During the course of manufacture of plasma products, viral inactivation
       procedures have been adopted based on chemical and physical principles.
       The distinct effects of these depend on methodology and the types of
       virus in question. An important safety measure relates to establishing
       that the label value of content corresponds to the in vivo recovery of
       the reconstituted plasma derivative and, by inference, the clinical
       efficacy of the product. In patients deficient in plasma coagulation
       factors, treatment may trigger the development of functionally
       inhibiting alloantibodies against the factor needed for substitution
       which is a significant clinical complication. The reported incidences of
       such inhibitors have varied greatly. No clear relationship between their
       frequency and the type of concentrate used have been established.
       However, recent experience has shown an unexpected increase in
       inhibitors in a regional subset of previously stable patients when
       shifted from a dry-heat-inactivated concentrate to a pasteurized version
       of the same concentrate. Hence, the possible introduction of neoantigens
       is important. In the early era of concentrate use, side effects to
       treatment were often observed like alloimmune hemolytic anemia and
       various degrees of anaphylactoid reactions. With the appearance of
       concentrates of increased purity that contain less unwarranted proteins,
       side effects of this kind have been rare. In conclusion, safety of
       plasma derivatives by today's standards is not a single entity, but a
       long chain of interdependent issues, each of which needs full attention
       to protect patients from mild and serious treatment complications.
 DE    Blood Coagulation Factors/*ADVERSE EFFECTS  Blood Component
       Transfusion/*ADVERSE EFFECTS  Blood Donors  Hepatitis/PREVENTION &
       CONTROL  Human  Immune Tolerance  Plasma/*CHEMISTRY  Safety  Virus
       Diseases/TRANSMISSION  JOURNAL ARTICLE  REVIEW  REVIEW, TUTORIAL

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