Clinical safety of platelets photochemically treated with amotosalen HCl and ultraviolet A light for pathogen inactivation: the SPRINT trial

• Published in: Transfusion (Philadelphia, Pa.) Vol. 45; no. 12; pp. 1864 - 1875
• Main Authors: Snyder, Edward, McCullough, Jeffrey, Slichter, Sherrill J., Strauss, Ronald G., Lopez-Plaza, Ileana, Lin, Jin-Sying, Corash, Laurence, Conlan, Maureen G.
• Format: Journal Article
• Language: English
• Published: Oxford, UK and Malden, USA Blackwell Science Inc 01.12.2005; Blackwell Publishing
• Subjects: Adult; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Bacteria - drug effects; Bacteria - radiation effects; Bacterial Infections - epidemiology; Bacterial Infections - prevention & control; Biological and medical sciences; Blood Banking - methods; Blood Banks - standards; Blood coagulation. Blood cells; Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis; Cause of Death; Emergency and intensive cardiocirculatory care. Cardiogenic shock. Coronary intensive care; Female; Fundamental and applied biological sciences. Psychology; Furocoumarins; Hemorrhage - epidemiology; Humans; Incidence; Intensive care medicine; Male; Medical sciences; Middle Aged; Molecular and cellular biology; Platelet; Platelet Transfusion - adverse effects; Plateletpheresis; Safety; Skin Diseases - epidemiology; Thrombocytopenia - mortality; Thrombocytopenia - therapy; Thrombosis - epidemiology; Transfusions. Complications. Transfusion reactions. Cell and gene therapy; Ultraviolet Rays; Platelet; Amotosalen; Treatment; Transfusion; Inactivation; Photochemotherapy
• ISSN: 0041-1132; 1537-2995
• DOI: 10.1111/j.1537-2995.2005.00639.x

BACKGROUND:  A photochemical treatment (PCT) method utilizing a novel psoralen, amotosalen HCl, with ultraviolet A illumination has been developed to inactivate viruses, bacteria, protozoa, and white blood cells in platelet (PLT) concentrates. A randomized, controlled, double‐blind, Phase III trial (SPRINT) evaluated hemostatic efficacy and safety of PCT apheresis PLTs compared to untreated conventional (control) apheresis PLTs in 645 thrombocytopenic oncology patients requiring PLT transfusion support. Hemostatic equivalency was demonstrated. The proportion of patients with Grade 2 bleeding was not inferior for PCT PLTs. STUDY DESIGN AND METHODS:  To further assess the safety of PCT PLTs, the adverse event (AE) profile of PCT PLTs transfused in the SPRINT trial is reported. Safety assessments included transfusion reactions, AEs, and deaths in patients treated with PCT or control PLTs in the SPRINT trial. RESULTS:  A total of 4719 study PLT transfusions were given (2678 PCT and 2041 control). Transfusion reactions were significantly fewer following transfusion of PCT than control PLTs (3.0% vs. 4.1%; p = 0.02). Overall AEs (99.7% PCT vs. 98.2% control), Grade 3 or 4 AEs (79% PCT vs. 79% control), thrombotic AEs (3.8% PCT vs. 3.7% control), and deaths (3.5% PCT vs. 5.2% control) were comparable between treatment groups. Minor hemorrhagic AEs (petechiae [39% PCT vs. 29% control; p < 0.01] and fecal occult blood [33% PCT vs. 25% control; p = 0.03]) and skin rashes (56% PCT vs. 42% control; p < 0.001) were significantly more frequent in the PCT group. CONCLUSION:  The overall safety profile of PCT PLTs was comparable to untreated PLTs.