Pharmacokinetic study of FFP photochemically treated with amotosalen (S-59) and UV light compared to FFP in healthy volunteers anticoagulated with warfarin.

Autor: Hambleton, Julie, Wages, David, Radu-Radulescu, Lucian, Adams, Melanie, McKenzie, Malcolm, Shafer, Steven, Lee, Martin, Smyers, Jocelyn, Wiesehahn, Gary, Corash, Laurence, MacKenzie, Malcolm
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Zdroj: Transfusion; Oct2002, Vol. 42 Issue 10, p1302-1307, 6p, 1 Chart, 2 Graphs
Abstrakt: Background: To date, no clinical trials have characterized FFP infusion efficacy, and infusion still carries infectious risk. This single-blinded crossover study compared postinfusion kinetics of FVII in photochemically treated FFP to standard FFP.Study Design and Methods: Subjects donated plasma by apheresis. Half of the collected plasma was treated with the psoralen amotosalen hydrochloride (S-59) and UVA light, and half were prepared as standard plasma. Subjects received warfarin over 4 days to lower FVII levels. On Day 4, subjects received 1 L of either treated or standard FFP. After 2 weeks, subjects underwent a regimen identical to that with the other type of FFP.Results: After warfarin ingestion, the mean FVII concentration was 0.33 IU per mL. Both types of FFP exhibited comparable FVII kinetics, with a mean peak increment of 0.10 to 0.12 IU per mL occurring at the end of infusion. The effect disappeared after 8 hours.Discussion: Study data of warfarin-treated healthy volunteers demonstrate that psoralen plus UV-treated FFP provides an equivalent in vivo coagulation response to control plasma. A 1-L dose of FFP in adults may provide an initial increment of 0.10 IU per mL of FVII. In the absence of bleeding, FVII levels return to baseline after 8 hours. [ABSTRACT FROM AUTHOR]
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