0
selected
-
1.
Clinical efficacy and safety of platelets in additive solution treated with two commercial pathogen reduction technologies
Rebulla P, Vaglio S, Aprili G, Beccaria F, Coluzzi S, Girelli G, Graf M, Isernia P, Marconi M, Olivero B, et al
Transfusion. 2015;55((Suppl. 3)):3A.. Abstract no. P2-030A.
-
2.
Persistence of lymphocytotoxic antibodies in patients in the trial to reduce alloimmunization to platelets: implications for using modified blood products
Slichter SJ, Bolgiano D, Kao KJ, Kickler TS, McFarland J, McCullough J, Woodson R
Transfusion Medicine Reviews. 2011;25((2):):102-10.
Abstract
Patients with acute myelogenous leukemia undergoing induction chemotherapy have significant decreases in alloimmune platelet refractoriness if they receive filter-leukoreduced or UV-B-irradiated vs standard platelet transfusions (3%-5% vs 13%, respectively; P <= .03) with no differences among the treated platelet arms (Trial to Reduce Alloimmunization to Platelets). Therefore, measuring antibody persistence might identify the best platelets for transfusion. Lymphocytotoxic (LCT) antibody duration was evaluated for association with patient age, sex, prior transfusion and pregnancy history, study-assigned platelet transfusions, and percentage LCT panel reactive antibodies. During the Trial to Reduce Alloimmunization to Platelets, 145 patients became antibody positive; and 81 (56%) of them subsequently became antibody negative. Using Kaplan-Meier estimates, projected antibody loss was 73% at 1 year. Major factors associated with antibody persistence were prior pregnancy and percentage panel reactive antibody positivity, whereas neither the assigned type of platelets transfused during the 8 weeks of the trial nor prior transfusion history was predictive. After 5 to 8 weeks, the number and type of blood products transfused had no effect on either antibody development or loss. A majority of patients with acute myelogenous leukemia who develop LCT antibodies during induction chemotherapy will lose their antibodies within 4 months regardless of the type or number of blood products they receive.
-
3.
Dose of prophylactic platelet transfusions and prevention of hemorrhage
Slichter SJ, Kaufman RM, Assmann SF, McCullough J, Triulzi DJ, Strauss RG, Gernsheimer TB, Ness PM, Brecher ME, Josephson CD, et al
The New England Journal of Medicine. 2010;362((7):):600-13.
Abstract
BACKGROUND We conducted a trial of prophylactic platelet transfusions to evaluate the effect of platelet dose on bleeding in patients with hypoproliferative thrombocytopenia. METHODS We randomly assigned hospitalized patients undergoing hematopoietic stem-cell transplantation or chemotherapy for hematologic cancers or solid tumors to receive prophylactic platelet transfusions at a low dose, a medium dose, or a high dose (1. 1x10(11), 2. 2x10(11), or 4. 4x10(11) platelets per square meter of body-surface area, respectively), when morning platelet counts were 10,000 per cubic millimeter or lower. Clinical signs of bleeding were assessed daily. The primary end point was bleeding of grade 2 or higher (as defined on the basis of World Health Organization criteria). RESULTS In the 1272 patients who received at least one platelet transfusion, the primary end point was observed in 71%, 69%, and 70% of the patients in the low-dose group, the medium-dose group, and the high-dose group, respectively (differences were not significant). The incidences of higher grades of bleeding, and other adverse events, were similar among the three groups. The median number of platelets transfused was significantly lower in the low-dose group (9. 25x10(11)) than in the medium-dose group (11. 25x10(11)) or the high-dose group (19. 63x10(11)) (P=0. 002 for low vs. medium, P<0. 001 for high vs. low and high vs. medium), but the median number of platelet transfusions given was significantly higher in the low-dose group (five, vs. three in the medium-dose and three in the high-dose group; P<0. 001 for low vs. medium and low vs. high). Bleeding occurred on 25% of the study days on which morning platelet counts were 5000 per cubic millimeter or lower, as compared with 17% of study days on which platelet counts were 6000 to 80,000 per cubic millimeter (P<0. 001). CONCLUSIONS Low doses of platelets administered as a prophylactic transfusion led to a decreased number of platelets transfused per patient but an increased number of transfusions given. At doses between 1. 1x10(11) and 4. 4x10(11) platelets per square meter, the number of platelets in the prophylactic transfusion had no effect on the incidence of bleeding. (ClinicalTrials. gov number, NCT00128713. )
-
4.
Effects of prophylactic platelet (Plt) dose on transfusion (Tx) outcomes (PLADO Trial)
Slichter SJ, Kaufman RM, Assmann SF, Brecher ME, Gernsheimer T, Hillyer CD, McCullough J, Strauss RG, Triulzi D
Blood. 2008;112((11):): Abstract No. 285.
-
5.
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.
-
6.
Factors affecting posttransfusion platelet increments, platelet refractoriness, and platelet transfusion intervals in thrombocytopenic patients
Slichter SJ, Davis K, Enright H, Braine H, Gernsheimer T, Kao KJ, Kickler T, Lee E, McFarland J, McCullough J, et al
Blood. 2005;105((10):):4106-14.
Abstract
A variety of patient and product-related factors influenced the outcome of 6379 transfusions given to 533 patients in the Trial to Reduce Alloimmunization to Platelets (TRAP). Responses measured were platelet increments, interval between platelet transfusions, and platelet refractoriness. Patient factors that improved platelet responses were splenectomy and increasing patient age. In contrast, at least 2 prior pregnancies, male gender, splenomegaly, bleeding, fever, infection, disseminated intravascular coagulation, increasing height and weight, lymphocytotoxic antibody positivity, an increasing number of platelet transfusions, or receiving heparin or amphotericin were associated with decreased posttransfusion platelet responses. Platelet factors that were associated with improved platelet responses were giving ABO-compatible platelets, platelets stored for 48 hours or less, and giving large doses of platelets while ultraviolet B (UV-B) or gamma irradiation decreased platelet responses. However, in alloimmunized lymphocytoxic antibody-positive patients, the immediate increment to UV-B-irradiated platelets was well maintained, whereas all other products showed substantial reductions. Refractoriness to platelet transfusions developed in 27% of the patients. Platelet refractoriness was associated with lymphocytotoxic antibody positivity, heparin administration, fever, bleeding, increasing number of platelet transfusions, increasing weight, at least 2 pregnancies, and male gender. The only factors that reduced platelet refractoriness rates were increasing the dose of platelets transfused or transfusing filtered apheresis platelets.
-
7.
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.
-
8.
Intercept platelets exhibit immunologic refractoriness comparable to conventional platelets
Strauss RG, Slichter S, Lopez-Plaza I, Goodnough LT, McCullough J, Lin J, Conlan MG
Haematologica. 2004;89((Suppl 5):):S216-7.. Abstract No. 628.
-
9.
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.
-
10.
Fresh (1-2 day-old) vs. aged (4-5 day-old) INTERCEPT platelets and conventional platelets provide comparable count increments. However fresh platelets result in superior hemostasis: results of the SPRINT trial
Benjamin RJ, Goodnough LT, Lopez-Perez I, Strauss R, McCullough J, Slichter S, Lin J
Transfusion. 2003;43((9S):):9A.. Abstract No. S29-030E.