Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial.
We report a transfusion trial of platelets photochemically treated for pathogen inactivation using the synthetic psoralen amotosalen HCl. Patients with thrombocytopenia were randomly assigned to receive either photochemically treated (PCT) or conventional (control) platelets for up to 28 days. The primary end point was the proportion of patients with World Health Organization (WHO) grade 2 bleeding during the period of platelet support. A total of 645 patients (318 PCT and 327 control) were evaluated. The primary end point, the incidence of grade 2 bleeding (58.5% PCT versus 57.5% control), and the secondary end point, the incidence of grade 3 or 4 bleeding (4.1% PCT versus 6.1% control), were equivalent between the 2 groups (P =.001 by noninferiority). The mean 1-hour posttransfusion platelet corrected count increment (CCI) (11.1 x 10(3) PCT versus 16.0 x 10(3) control), average number of days to next platelet transfusion (1.9 PCT versus 2.4 control), and number of platelet transfusions (8.4 PCT versus 6.2 control) were different (P <.001). Transfusion reactions were fewer following PCT platelets (3.0% PCT versus 4.4% control; P =.02). The incidence of grade 2 bleeding was equivalent for PCT and conventional platelets, although posttransfusion platelet count increments and days to next transfusion were decreased for PCT compared with conventional platelets.
McCullough
Jeffrey
J
University of Minnesota, MMC 609, 420 Delaware Street SE, Minneapolis, MN 55455, USA. mccul001@umn.edu
Vesole
David H
DH
Benjamin
Richard J
RJ
Slichter
Sherrill J
SJ
Pineda
Alvaro
A
Snyder
Edward
E
Stadtmauer
Edward A
EA
Lopez-Plaza
Ileana
I
Coutre
Steven
S
Strauss
Ronald G
RG
Goodnough
Lawrence T
LT
Fridey
Joy L
JL
Raife
Thomas
T
Cable
Ritchard
R
Murphy
Scott
S
Howard
Frank
F
Davis
Kathryn
K
Lin
Jin-Sying
JS
Metzel
Peyton
P
Corash
Laurence
L
Koutsoukos
Antonis
A
Lin
Lily
L
Buchholz
Donald H
DH
Conlan
Maureen G
MG
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001792:Blood Platelets / Q000187:drug effects*; D017848:Blood-Borne Pathogens; D002648:Child; D017707:Erythrocyte Transfusion; D005260:Female; D011564:Furocoumarins / Q000494:pharmacology*; D006470:Hemorrhage / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D010777:Photochemistry; D017713:Platelet Transfusion / Q000009:adverse effects; D011446:Prospective Studies; D013921:Thrombocytopenia / Q000628:therapy*
D011564:Furocoumarins; C118577:amotosalen