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. STUDY DESIGN AND METHODS : Subjects donated plasma...
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| Published in | Transfusion (Philadelphia, Pa.) Vol. 42; no. 10; pp. 1302 - 1307 |
|---|---|
| Main Authors | , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Boston, MA, USA
Blackwell Science Inc
01.10.2002
Blackwell Publishing |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0041-1132 1537-2995 |
| DOI | 10.1046/j.1537-2995.2002.00220.x |
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| Abstract | 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. |
|---|---|
| AbstractList | 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.
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.
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.
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. 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.BACKGROUNDTo 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.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.STUDY DESIGN AND METHODSSubjects 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.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.RESULTSAfter 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.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.DISCUSSIONStudy 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. 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. 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. |
| Author | Lee, Martin Smyers, Jocelyn Shafer, Steven Hambleton, Julie Wages, David Radu-Radulescu, Lucian Adams, Melanie MacKenzie, Malcolm Wiesehahn, Gary Corash, Laurence |
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| Keywords | Human Blood coagulation Warfarin Transfusion Fresh frozen plasma Photochemical method Anticoagulant Method Crossover study Factor VII Ultraviolet radiation Pharmacokinetics Coagulation factor Comparative study Psoralen derivatives Quantitative analysis |
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| Snippet | BACKGROUND : To date, no clinical trials have characterized FFP infusion efficacy, and infusion still carries infectious risk. This single‐blinded crossover... BACKGROUND : To date, no clinical trials have characterized FFP infusion efficacy, and infusion still carries infectious risk. This single‐blinded crossover... To date, no clinical trials have characterized FFP infusion efficacy, and infusion still carries infectious risk. This single-blinded crossover study compared... |
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| SubjectTerms | Adult Aged Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy Anticoagulants - therapeutic use Biological and medical sciences Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis Cross-Over Studies Factor VII - analysis Furocoumarins - pharmacology Humans Infection Control - methods Medical sciences Middle Aged Pharmacokinetics Photochemistry Photosensitizing Agents - pharmacology Plasma - drug effects Plasma - radiation effects Prospective Studies Single-Blind Method Transfusions. Complications. Transfusion reactions. Cell and gene therapy Ultraviolet Rays Warfarin - therapeutic use |
| Title | Pharmacokinetic study of FFP photochemically treated with amotosalen (S-59) and UV light compared to FFP in healthy volunteers anticoagulated with warfarin |
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