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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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Submitted January 8, 2004
Accepted April 12, 2004

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 Stadtmauer, Ileana Lopez-Plaza, Steven Coutre, Ronald G Strauss, Lawrence T Goodnough, Joy L Fridey, Thomas Raife, Ritchard Cable, Scott Murphy, Frank Howard, Kathryn Davis, Jin-Sying Lin, Peyton Metzel, Laurence Corash, Antonis Koutsoukos, Lily Lin, Donald Buchholz, and Maureen Conlan

Lab. Med. & Path., University of Minnesota, Minneapolis, MN, USA
Blood & Marrow Transplant Program, Medical College of Wisconsin, Milwaukee, WI, USA
Transfusion Medicine, Brigham & Women's Hospital, Boston, MA, USA
Transfusion Medicine, Puget Sound Blood Center, Seattle, WA, USA
Transfusion Medicine, Mayo Clinic, Rochester, MN, USA
School of Medicine, Yale-New Haven Hospital, New Haven, CT, USA
University of Pennsylvania Medical Center, Philadelphia, PA, USA
Institute for Transfusion Medicine, Pittsburgh, PA, USA
Stanford Medical Center, Palo Alto, CA, USA
DeGowin Blood Center, University of Iowa, Iowa City, IA, USA
Washington University School of Medicine, St. Louis, MO, USA
Blood Bank of San Bernadino County, San Bernadino, CA, USA
Blood Center of Southeastern Wisconsin, Milwaukee, WI, USA
American Red Cross Blood Services, Farmington, CT, USA
Penn-Jersey Region, American Red Cross Blood Services, Philadelphia, PA, USA
Loma Linda University Cancer Institute, Loma Linda, CA, USA
University of Washington, Seattle, WA, USA
Cerus Corporation, Concord, CA, USA
Baxter Healthcare Corporation, Round Lake, IL, USA
Quintiles, Inc., Rockville, MD, USA

* Corresponding author; email: mccul001{at}umn.edu.

We report a transfusion trial of platelets photochemically treated for pathogen inactivation using the synthetic psoralen amotosalen HCl. Thrombocytopenic patients were randomized to receive either photochemically treated (PCT) or conventional (control) platelets for up to 28 days. The primary endpoint was the proportion of patients with WHO Grade 2 bleeding during the period of platelet support. 645 patients (318 PCT vs. 327 control) were evaluated. The primary endpoint, the incidence of Grade 2 bleeding (58.5% PCT vs. 57.5% control), and the secondary endpoint, the incidence of Grade 3 or 4 bleeding (4.1% PCT vs. 6.1% control), were equivalent between the two groups (p < .001 by non-inferiority). The mean 1-hour post transfusion platelet corrected count increment (CCI) (11.1 x 103 PCT vs. 16.0 x 103 control), average number of days-to-next platelet transfusion (1.9 PCT vs. 2.4 control), and number of platelet transfusions (8.4 PCT vs. 6.2 control) were different (p < 0.001). Transfusion reactions were fewer following PCT platelets (3.0% PCT vs. 4.4% control; p = 0.02). The incidence of Grade 2 bleeding was equivalent for PCT and conventional platelets, although post-transfusion platelet count increments and days-to-next transfusion were decreased for PCT compared to conventional platelets.


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