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Blood, 1 September 2004, Vol. 104, No. 5, pp. 1534-1541.
Prepublished online as a Blood First Edition Paper on May 11, 2004; DOI 10.1182/blood-2003-12-4443.
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TRANSFUSION MEDICINE
Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial
Jeffrey McCullough,
David H. Vesole,
Richard J. Benjamin,
Sherrill J. Slichter,
Alvaro Pineda,
Edward Snyder,
Edward A. Stadtmauer,
Ileana Lopez-Plaza,
Steven Coutre,
Ronald G. Strauss,
Lawrence T. Goodnough,
Joy L. Fridey,
Thomas Raife,
Ritchard Cable,
Scott Murphy,
Frank Howard, IV,
Kathryn Davis,
Jin-Sying Lin,
Peyton Metzel,
Laurence Corash,
Antonis Koutsoukos,
Lily Lin,
Donald H. Buchholz, and
Maureen G. Conlan
From the Department of Laboratory Medicine & Pathology, University of Minnesota, Minneapolis; the Blood and Marrow Transplant Program, Medical College of Wisconsin, Milwaukee; the Joint Program in Transfusion Medicine, Brigham & Women's Hospital, Boston, MA; Puget Sound Blood Center, Seattle, WA; the Department of Laboratory Medicine, Mayo Clinic, Rochester, MN; Yale University School of Medicine, Yale-New Haven Hospital, New Haven, CT; University of Pennsylvania Medical Center, Philadelphia; Institute for Transfusion Medicine, Pittsburgh, PA; Stanford Medical Center, Palo Alto, CA; DeGowin Blood Center, University of Iowa, Iowa City; Washington University School of Medicine, St Louis, MO; Blood Bank of San Bernadino County, San Bernadino, CA; Blood Center of Southeastern Wisconsin, Milwaukee; American Red Cross Blood Services, Farmington, CT; American Red Cross Blood Services, Penn-Jersey Region, Philadelphia, PA; Loma Linda University Cancer Institute, Loma Linda, CA; University of Washington, Seattle; Cerus Corp, Concord, CA; Quintiles Inc, Rockville, MD; and Baxter Healthcare Corp, Round Lake, IL.
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 103 PCT versus 16.0 x 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.

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