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A multi-centre study of therapeutic efficacy and safety of platelet components treated with amotosalen and ultraviolet A pathogen inactivation stored for 6 or 7 d prior to transfusion
Lozano M, Knutson F, Tardivel R, Cid J, Maymo RM, Lof H, Roddie H, Pelly J, Docherty A, Sherman C, et al
British Journal of Haematology. 2011;153((3):):393-401.
Abstract
Bacteria in platelet components (PC) may result in transfusion-related sepsis (TRS). Pathogen inactivation of PC with amotosalen (A-PC) can abrogate the risk of TRS and hence facilitate storage to 7 d. A randomized, controlled, double-blinded trial to evaluate the efficacy and safety of A-PC stored for 6-7 d was conducted. Patients were randomized to receive one transfusion of conventional PC (C-PC) or A-PC stored for 6-7 d. The primary endpoint was the 1 h corrected count increment (CCI) with an acceptable inferiority of 30%. Secondary endpoints included 1- and 24-h count increment (CI), 24-h CCI, time to next PC transfusion, red blood cell (RBC) use, bleeding and adverse events. 101 and 100 patients received A-PC or C-PC respectively. The ratio of 1-h CCI (A-PC:C-PC) was 0·87 (95% confidence interval: 0·73, 1·03) demonstrating non-inferiority (P = 0·007), with respective mean 1-h CCIs of 8163 and 9383; mean 1-h CI was not significantly different. Post-transfusion bleeding and RBC use were not significantly different (P = 0·44, P = 0·82 respectively). Median time to the next PC transfusion after study PC was not significantly different between groups: (2·2 vs. 2·3 d, P = 0·72). Storage of A-PCs for 6-7 d had no impact on platelet efficacy.
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A multi-center study of therapeutic efficacy and safety of platelet components prepared with pathogen inactivation (INTERCEPT) stored for 6 or 7 days prior to transfusion
Lozano M, Knutson N, Tardivel R, Cid J, Maymo R, Lof HM, Roddie HP, Pelly JP, Docherty AR, Sherman CD, et al
Vox Sanguinis. 2010;99((Suppl S1):):13. Abstract No. 3B-S07-03.
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Frequency of prophylactic transfusion failure: a novel outcome to evaluate platelet components stored more than 5 days
Lozano M, Knutson F, Tardivel R, Cid J, Maymó R, Löf H, Roddie H, Lin L, Corash L, Prowse C
Transfusion. 2010;50((Suppl 2):):25A-26A.. Abstract No. S54-030D.
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4.
Transfusion of 7-day-old amotosalen photochemically treated buffy-coat platelets to patients with thrombocytopenia: a pilot study
Simonsen AC, Johansson PI, Conlan MG, Jacquet M, Lin JS, Junge K, Lin L, Sørensen H, Borregaard N, Flament J
Transfusion. 2006;46((3):):424-33.
Abstract
BACKGROUND Photochemical treatment (PCT) of platelets (PLTs) with amotosalen and ultraviolet A light to inactivate bacteria may facilitate extension of storage from 5 to 7 days. STUDY DESIGN AND METHODS A randomized, double-blinded, crossover, noninferiority, single-site pilot study utilizing pooled buffy-coat PLTs was conducted. The primary endpoint was the 1-hour corrected count increment (CCI) after one transfusion each of 7-day-old PCT and reference (R) PLT components. Secondary endpoints included 1-hour count increment, time to next transfusion, hemostasis, transfusion reactions, and serious adverse events. RESULTS Twenty patients with thrombocytopenia were randomly assigned: 9 to the PCT-R sequence and 11 to the R-PCT sequence. A significant treatment-by-period interaction was observed. Therefore, the first period only was also analyzed for the primary endpoint. Including both treatment periods, mean 1-hour CCI was 6587 +/- 4531 for PCT versus 8935 +/- 5478 for R-PLTs. For the first period only, mean 1-hour CCI was 8739 +/- 3785 for PCT versus 7433 +/- 5408 for R-PLTs. The upper bound of the one-sided 95 percent confidence interval of 2400 for the mean difference was higher than the specified noninferiority margin of 2200 for both analyses. Overall median time to next transfusion was 22 hours for PCT versus 27 hours for R-PLTs. Hemostasis was adequate and no transfusion reactions or serious adverse events were reported. CONCLUSIONS Although this pilot study of a limited number of patients failed to show noninferiority within the specified noninferiority margin, 7-day-old PCT PLTs showed acceptable efficacy and safety for support of thrombocytopenia. The results, however, warrant evaluation in a larger trial of 7-day-old PCT PLTs.
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Therapeutic efficacy and safety of photochemically treated apheresis platelets processed with an optimized integrated set
Janetzko K, Cazenave JP, Klüter H, Kientz D, Michel M, Beris P, Lioure B, Hastka J, Marblie S, Mayaudon V, et al
Transfusion. 2005;45((9):):1443-52.
Abstract
BACKGROUND This multicenter, randomized, controlled, double-blind Phase III clinical study evaluated the therapeutic efficacy and safety of apheresis platelets (PLTs) photochemically treated (PCT) with amotosalen and ultraviolet A light (INTERCEPT Blood System, Baxter Healthcare Corp.) compared with conventional apheresis PLTs (reference). STUDY DESIGN AND METHODS Forty-three patients with transfusion-dependent thrombocytopenia were randomly assigned to receive either PCT or reference PLT transfusions for up to 28 days. RESULTS The mean 1- and 24-hour corrected count increments were lower in response to PCT PLTs (not significant). When analyzed by longitudinal regression analysis, the estimated effect of treatment on 1-hour PLT count was a decrease of 7. 2 x 10(9) per L (p = 0. 05) and on 24-hour PLT count a decrease of 7. 4 x 10(9) per L (p = 0. 04). Number, frequency, and dose of PLT transfusions; acute transfusion reactions; and adverse events were similar between the two groups. There was no transfusion-associated bacteremia. Four PCT patients experienced clinical refractoriness; however, only one exhibited lymphocytotoxicity assay seroconversion. Antibodies against potential amotosalen-related neoantigens were not detected. CONCLUSION PCT PLTs provide effective and safe transfusion support for thrombocytopenic patients.
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6.
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 platelet concentrates (LPC) are effective and safe for support of multiple cycles of thrombocytopenia: the EUROSPRITE Phase III Trial
Corash L, Klueter H, Rhenen Dv, Gulliksson H, Pamphilon D, Cazenave JP, Ljungman P, Davis K, Flament J, Marblie S, et al
Haematologica. 2001;86((Suppl 1):): Abstract No. 667.
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Double-dose intercept platelets collected by apheresis retain in vitro function
Corash LM, Janetzko K, Eichler H, Lin L, Flament J, Klueter H
Haematologica. 2001;86((Suppl 1):): Abstract No. 670.
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10.
THE EUROSPRITE phase III trial of INTERCEPT buffy coat platelet concentrates (IPC) demonstrates IPC are safe when transfused to thrombocytopenic (TCP) patients (PTS)
Pamphilon D, Buchholz DH, Cazenave JP, Conlan M, Corash L, Davis K, Flament J, Gulliksson H, Lin L, Ljungman P, et al
Transfusion clinique et biologique. 2001;8((Suppl 1):):100-101s.. Abstract No. P148.