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

Autor: Julie Hambleton, Gary Wiesehahn, Lucian Radu-Radulescu, David Wages, Martin Lee, Laurence Corash, Melanie Adams, Malcolm R. Mackenzie, Steven L. Shafer, Jocelyn Smyers
Rok vydání: 2002
Předmět:
Zdroj: Transfusion. 42:1302-1307
ISSN: 1537-2995
0041-1132
Popis: 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.
Databáze: OpenAIRE
Externí odkaz: