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Platelets photochemically treated with amotosalen HCl and ultraviolet A light correct prolonged bleeding times in patients with thrombocytopenia
Slichter SJ, Raife TJ, Davis K, Rheinschmidt M, Buchholz DH, Corash L, Conlan MG
Transfusion. 2006;46((5):):731-40.
Abstract
BACKGROUND Photochemical treatment (PCT) with amotosalen HCl with ultraviolet A illumination inactivates pathogens and white blood cells in platelet (PLT) concentrates. STUDY DESIGN AND METHODS In a Phase II crossover study, 32 patients with thrombocytopenia received one transfusion of PCT and/or one transfusion of untreated (reference) apheresis PLTs. Hemostatic efficacy was assessed with the cutaneous template bleeding time and clinical observations. RESULTS Paired bleeding time data for PCT and reference transfusions were available for 10 patients. Mean pretransfusion bleeding times were 29. 2 +/- 1. 6 minutes in the PCT group and 28. 7 +/- 2. 5 minutes in the reference group. After transfusion of a dose of PLTs of at least 6. 0 x 10(11), mean 1-hour posttransfusion template bleeding times corrected to 19. 3 +/- 9. 5 minutes in the PCT group and 14. 3 +/- 6. 5 minutes in the reference group (p = 0. 25). In 29 patients receiving paired PCT and reference transfusions, mean 1-hour posttransfusion PLT count increments were 41. 9 x 10(9) +/- 20. 8 x 10(9) and 52. 3 x 10(9) +/- 18. 3 x 10(9) per L for PCT and reference, respectively (p = 0. 007), and mean 1-hour posttransfusion PLT corrected count increments (CCIs) were 10. 4 x 10(3) +/- 4. 9 x 10(3) and 13. 6 x 10(3) +/- 4. 3 x 10(3) for PCT and reference, respectively (p < 0. 001). The time to next PLT transfusion was 2. 9 +/- 1. 2 days after PCT transfusions versus 3. 4 +/- 1. 3 days after reference transfusions (p = 0. 18). Clinical hemostasis was not significantly different after PCT and reference transfusions. CONCLUSION PCT PLTs provided correction of prolonged bleeding times and transfusion intervals not significantly different than reference PLTs despite significantly lower PLT count increments and CCIs.
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Platelet dose consistency and its effect on the number of platelet transfusions for support of thrombocytopenia: an analysis of the SPRINT trial of platelets photochemically treated with amotosalen HCl and ultraviolet A light
Murphy S, Snyder E, Cable R, Slichter SJ, Strauss RG, McCullough J, Lin JS, Corash L, Conlan MG, SPRINT Study Group
Transfusion. 2006;46((1):):24-33.
Abstract
BACKGROUND The SPRINT trial examined efficacy and safety of photochemically treated (PCT) platelets (PLTs). PCT PLTs were equivalent to untreated (control) PLTs for prevention of bleeding. Transfused PLT dose and corrected count increments (CIs), however, were lower and transfusion intervals were shorter for PCT PLTs, resulting in more PCT than control transfusions. PLT dose was analyzed to determine the impact of the number of PLTs transfused on transfusion requirements. STUDY DESIGN AND METHODS Transfusion response was compared for patients with all doses of >or=3. 0 x 10(11) and the complementary subset of patients with any dose of fewer than 3. 0 x 10(11). Analyses included comparison of bleeding, number of PLT and red blood cell (RBC) transfusions, transfusion intervals, and CIs between PCT and control groups within each PLT dose subset. RESULTS Mean PLT dose per transfusion in the PCT group was lower than in the control group (3. 7 x 10(11) vs. 4. 0 x 10(11); p<0. 001). More PCT patients received PLT doses of fewer than 3. 0 x 10(11) (n=190) than control patients (n=118; p<0. 01). Comparisons of patients receiving comparable PLT doses showed no significant differences between PCT and control groups for bleeding or number of PLT or RBC transfusions; however, transfusion intervals and CIs were significantly better for the control group. CONCLUSIONS When patients were supported with comparable doses of PCT or conventional PLTs, the mean number of PLT transfusions was similar. Lower CIs and shorter transfusion intervals for PCT PLTs suggest that some PLT injury may occur during PCT. This injury does not result in a detectable increase in bleeding, however.
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Clinical safety of platelets photochemically treated with amotosalen HCl and ultraviolet A light for pathogen inactivation: the SPRINT trial
Snyder E, McCullough J, Slichter SJ, Strauss RG, Lopez-Plaza I, Lin JS, Corash L, Conlan MG, SPRINT Study Group
Transfusion. 2005;45((12):):1864-75.
Abstract
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.
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Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial
McCullough J, Vesole DH, Benjamin RJ, Slichter SJ, Pineda A, Snyder E, Stadtmauer EA, Lopez-Plaza I, Coutre S, Strauss RG, et al
Blood. 2004;104((5):):1534-41.
Abstract
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.
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Transfusion of pooled buffy coat platelet components prepared with photochemical pathogen inactivation treatment: the euroSPRITE trial
van Rhenen D, Gulliksson H, Cazenave JP, Pamphilon D, Ljungman P, Klüter H, Vermeij H, Kappers-Klunne M, de Greef G, Laforet M, et al
Blood. 2003;101((6):):2426-33.
Abstract
A nucleic acid-targeted photochemical treatment (PCT) using amotosalen HCl (S-59) and ultraviolet A (UVA) light was developed to inactivate viruses, bacteria, protozoa, and leukocytes in platelet components. We conducted a controlled, randomized, double-blinded trial in thrombocytopenic patients requiring repeated platelet transfusions for up to 56 days of support to evaluate the therapeutic efficacy and safety of platelet components prepared with the buffy coat method using this pathogen inactivation process. A total of 103 patients received one or more transfusions of either PCT test (311 transfusions) or conventional reference (256 transfusions) pooled, leukoreduced platelet components stored for up to 5 days before transfusion. More than 50% of the PCT platelet components were stored for 4 to 5 days prior to transfusion. The mean 1-hour corrected count increment for up to the first 8 test and reference transfusions was not statistically significantly different between treatment groups (13,100 +/- 5400 vs 14,900 +/- 6200, P =. 11). By longitudinal regression analysis for all transfusions, equal doses of test and reference components did not differ significantly with respect to the 1-hour (95% confidence interval [CI], -3. 1 to 6. 1 x 10(9)/L, P =. 53) and 24-hour (95% CI, -1. 3 to 6. 5 x 10(9)/L, P =. 19) posttransfusion platelet count. Platelet transfusion dose, pretransfusion storage duration, and patient size were significant covariates (P <. 001) for posttransfusion platelet counts. Clinical hemostasis, hemorrhagic adverse events, and overall adverse events were not different between the treatment groups. Platelet components prepared with PCT offer the potential to further improve the safety of platelet transfusion using technology compatible with current methods to prepare buffy coat platelet components.
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INTERCEPT platelets (plts) and conventional plts provide comparable hemostatic responses in thrombocytopenic patients: the SPRINT trial
Slichter SJ, Murphy S, Buchholz D, Lin J, Corash L, Conlan M
Blood. 2002;100((11, Pt 2):):141b.. Abstract No. 4048.