TY - JOUR
T1 - Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation
T2 - The SPRINT trial
AU - McCullough, Jeffrey
AU - Vesole, David H.
AU - Benjamin, Richard J.
AU - Slichter, Sherrill J.
AU - Pineda, Alvaro
AU - Snyder, Edward
AU - Stadtmauer, Edward A.
AU - Lopez-Plaza, Ileana
AU - Coutre, Steven
AU - Strauss, Ronald G.
AU - Goodnough, Lawrence T.
AU - Fridey, Joy L.
AU - Raife, Thomas
AU - Cable, Ritchard
AU - Murphy, Scott
AU - Howard IV, Frank
AU - Davis, Kathryn
AU - Lin, Jin Sying
AU - Metzel, Peyton
AU - Corash, Laurence
AU - Koutsoukos, Antonis
AU - Lin, Lily
AU - Buchholz, Donald H.
AU - Conlan, Maureen G.
PY - 2004/9/1
Y1 - 2004/9/1
N2 - We report a transfusion trial of platelets photochemically treated for pathogen inactivation using the synthetic psoralen amotosalen HCI. 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 × 103 PCT versus 16.0 × 103 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.
AB - We report a transfusion trial of platelets photochemically treated for pathogen inactivation using the synthetic psoralen amotosalen HCI. 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 × 103 PCT versus 16.0 × 103 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.
UR - http://www.scopus.com/inward/record.url?scp=4444380592&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=4444380592&partnerID=8YFLogxK
U2 - 10.1182/blood-2003-12-4443
DO - 10.1182/blood-2003-12-4443
M3 - Article
C2 - 15138160
AN - SCOPUS:4444380592
SN - 0006-4971
VL - 104
SP - 1534
EP - 1541
JO - Blood
JF - Blood
IS - 5
ER -