Plasma exchange donation of cryoprecipitate after DDAVP stimulation: an alternative source of factor VIII.

The last few paragraphs will summarize pertinent characteristics of this material in relation to other current sources of factor VIII. First, at a time when safety is the paramount concern in hemophilia therapy, plasma exchange donation offers a product with a very low intrinsic risk of blood borne infection; in many cases, this risk can be equivalent to a single unit of blood. This is much lower than previous versions of commercial factor VIII and much lower than the intrinsic risk of the starting material for current products. We believe this risk is low enough to justify its use without viral inactivation, although certain additional measures, such as the 6-month quarantine devised by Dr. Noel, could increase the margin of safety even further. Note that the principle of limitation of donor exposure is a proven one, which should be effective against any infectious agents, including those unknown to us at this time. Second, at a time when efforts to improve the safety of commercial factor VIII have led to extraordinary increases in cost, factor VIII from plasma exchange donation promises to be relatively inexpensive. Our data indicate that most blood centers could produce factor VIII in this way at 25-50% of the price of the newest commercial products. Finally, there is the matter of supply. At present, commercial factor VIII is in short supply. It may be that worldwide demand for other plasma derivatives, combined with the reduced yield of factor VIII associated with viral inactivation measures, will dictate chronic shortages for the forseeable future. In this unsettled milieu, plasma exchange donation offers a new source of factor VIII, which need not be tied to the supply of, or demand for any other plasma products. Instead, it depends on local initiatives in blood banks and hemophilia centers, and donor activity that can be tailored specifically to the needs of hemophilia patients. Thus, in spite of the impressive advances in the safety of commercial factor VIII which have recently been implemented, we believe there is a place for single donor cryoprecipitate from plasma exchange donation in the treatment of hemophilia and other bleeding disorders in the 1990's. Its use should be more widely and more extensively investigated.