CLINICAL PRACTICE GUIDELINES
Hemophilia and von Willebrand’s Disease: 2. Management
(Edition 2, Update 2 [1999-07-07])

Blood components
Currently, all plasma-derived clotting-factor concentrates except cryoprecipitate undergo viral inactivation procedures. Prospective studies involving previously untransfused patients indicated that when these products are subjected to current virucidal treatments the risk of HIV and hepatitis C virus transmission is substantially reduced.<16,39,40 > Current virucidal procedures include: (a) pasteurization at 60 degrees C for 10 hours, (b) vapour heating at 60 degrees C for 10 hours at 1160 mbar pressure, (c) dry heating at 80 degrees C for 72 hours, (d) solvent-detergent treatment with tri(n-butyl) phosphate and Tween 80 or Triton X-100 or cholate, (e) solvent/detergent treatment plus heating (e.g. dry heating at 80 degrees C for 72 hours or 100 degrees C for 30 minutes, or pasteurization) or nanofiltration, and (f) sodium thiocyanate plus ultrafiltration. Although viral removal and inactivation procedures are highly effective, they cannot offer absolute protection. Therefore, all patients who are expected to receive blood products should be vaccinated against hepatitis B. None of the viral inactivation procedures is expected to inactivate every virus in the concentrate. For example, non-lipid-enveloped viruses such as parvovirus and hepatitis A virus, as well as unknown viruses and prions, such as the agent that causes Creutzfeldt-Jakob disease (CJD), may not be eliminated, and could be transmitted. We recommend vaccination against hepatitis A for patients who have tested negative for IgG antibodies to hepatitis A virus and who are likely to receive plasma-derived coagulation products. At present, no product can be considered unequivocally free from contaminating viruses. Even recombinant clotting-factors could potentially be contaminated by unknown animal viruses in the cell lines or fetal calf serum in which they are initially grown. Human plasma protein fractions are also required for cell cultures for the production of recombinant factor VIII. Currently licensed recombinant factor VIII products also use plasma-derived human albumin as a stabilizer (although human albumin is not used for the licensed recombinant factor IX concentrate and for the B-domainless recombinant factor VIII concentrate now in clinical trials).

In Canada, coagulation products for the management of inherited bleeding disorders are licensed by the Bureau of Biologicals and Radiopharmaceuticals (BBR), Health Canada. Blood products for all Canadians except those in the Province of Quebec are funded, purchased and distributed by the Canadian Blood Services (CBS). Blood products in Québec are funded, purchased and distributed by Héma Québec. The AHCDC makes requests with regard to the classes of concentrates to be made available for patient care, but the purchase and distribution of specific brands depends on contract negotiations that take several considerations, including cost, into account. Table 1 gives details on coagulation-factor concentrates currently funded by, and available from, the Canadian Blood Services and Héma Québec. To obtain products not licensed by the Bureau of Biologicals and Radiopharmaceutics, approval by the Special Access Program of the Bureau of Biologicals and Radiopharmaceutics, Health Canada is required.

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