Fresh frozen plasma prepared with amotosalen HCl (S-59) photochemical pathogen inactivation: transfusion of patients with congenital coagulation factor deficiencies.
BACKGROUND
Photochemical treatment (PCT) with amotosalen HCl (S-59) was developed to inactivate pathogens and white blood cells in plasma (PCT-FFP) used for transfusion support.


METHODS
An open-label, multicenter trial was conducted in patients with congenital coagulation factor deficiencies (factors [F]I, FII, FV, FVII, FX, FXI, and FXIII and protein C) to measure the kinetics of specific coagulation factors, hemostatic efficacy, and safety of PCT-FFP. Posttransfusion prothrombin time (PT), partial thromboplastin time (PTT), and clinical hemostasis were evaluated before and after PCT-FFP transfusions.


RESULTS
Thirty-four patients received 107 transfusions of PCT-FFP for kinetic studies or therapeutic indications (mean dose, 12.8 +/- 8.5 mL/kg). Incremental factor recoveries ranged from 0.9 to 2.4 IU per dL per IU per kg (FII, FV, FVII, FX, FXI, and protein C). Mean pretransfusion PT (20.7 +/- 22.2 sec) corrected after PCT-FFP (13.8 +/- 2.4 sec, p < 0.001). Mean pretransfusion PTT (51.2 +/- 29.3 sec) corrected after PCT-FFP (32.0 +/- 5.1 sec, p < 0.001). Thirteen patients required 77 transfusions for therapeutic indications. PCT-FFP provided effective hemostasis and was well tolerated.


CONCLUSIONS
Replacement coagulation factors in PCT-FFP exhibited kinetics and therapeutic efficacy consistent with conventional FFP.
de Alarcon
Pedro
P
Department of Pediatric Hematology, University of Virginia, Charlottesville, Virginia, USA.
Benjamin
Richard
R
Dugdale
Marion
M
Kessler
Craig
C
Shopnick
Rinah
R
Smith
Peter
P
Abshire
Thomas
T
Hambleton
Julie
J
Matthew
Prasad
P
Ortiz
Idith
I
Cohen
Alice
A
Konkle
Barbara A
BA
Streiff
Michael
M
Lee
Martin
M
Wages
David
D
Corash
Laurence
L
D000293:Adolescent; D000328:Adult; D000368:Aged; D001778:Blood Coagulation Disorders / Q000097:blood / Q000628:therapy*; D001779:Blood Coagulation Factors; D001793:Blood Preservation; D001803:Blood Transfusion; D002648:Child; D002675:Child, Preschool; D005260:Female; D011564:Furocoumarins / Q000494:pharmacology; D006487:Hemostasis; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D010949:Plasma; D011517:Prothrombin Time
D001779:Blood Coagulation Factors; D011564:Furocoumarins; C118577:amotosalen