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


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.


CONCLUSIONS
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.
Hambleton
Julie
J
Department of Medicine, General Clinical Research Center, Moffitt Hospital, University of California-San Francisco, San Francisco, CA, USA.
Wages
David
D
Radu-Radulescu
Lucian
L
Adams
Melanie
M
MacKenzie
Malcolm
M
Shafer
Steven
S
Lee
Martin
M
Smyers
Jocelyn
J
Wiesehahn
Gary
G
Corash
Laurence
L
D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D018592:Cross-Over Studies; D005167:Factor VII / Q000032:analysis; D011564:Furocoumarins / Q000494:pharmacology*; D006801:Humans; D017053:Infection Control / Q000379:methods*; D008875:Middle Aged; D010599:Pharmacokinetics; D010777:Photochemistry; D017319:Photosensitizing Agents / Q000494:pharmacology*; D010949:Plasma / Q000187:drug effects* / Q000528:radiation effects; D011446:Prospective Studies; D016037:Single-Blind Method; D014466:Ultraviolet Rays; D014859:Warfarin / Q000627:therapeutic use
D000925:Anticoagulants; D011564:Furocoumarins; D017319:Photosensitizing Agents; D014859:Warfarin; D005167:Factor VII; C118577:amotosalen