Transfusion of irradiated red blood cell units with a potassium adsorption filter: A randomized controlled trial
BACKGROUND The irradiation of red blood cells (RBCs) causes damage of the RBC membrane with increased potassium (K) leak during storage compared with nonirradiated RBC units of similar age. A previous in vitro study showed a mean reduction of K of 94 +/- 5% with a potassium adsorption filter (PAF). STUDY DESIGN AND METHODS A prospective, single-center, nonblinded, randomized controlled trial (RCT) was designed to evaluate the safety and efficacy of transfusing irradiated RBC units with the PAF. Patients 18 years of age or older who received irradiated RBC units due to chemotherapy-induced anemia were randomly assigned to receive irradiated RBC units with the PAF (PAF group) or with the standard blood infusion set (control group). Primary outcome measures were safety and efficacy of the PAF (absolute change in hemoglobin [Hb] and K, respectively, in patient's blood values after transfusing the irradiated RBC units with or without the PAF). RESULTS A total of 63 irradiated RBC units were transfused to 17 patients in the control group, and a total of 56 irradiated RBC units were transfused to 13 patients in the PAF group. The absolute change of Hb (9.3 +/- 6.3 g/L vs. 8.1 +/- 5.8 g/L; p = 0.3) and the absolute change of K (-0.01 +/- 0.4 mmol/L vs. -0.01 +/- 0.3 mmol/L; p = 0.2) were comparable between the two groups of the trial. CONCLUSION The transfusion of 1 irradiated RBC unit with the PAF was as safe and efficacious as the transfusion of 1 irradiated RBC unit with the standard blood infusion set in patients with chemotherapy-induced anemia.
Therapeutic efficacy of platelet components treated with amotosalen and ultraviolet A pathogen inactivation method: results of a meta-analysis of randomized controlled trials
Vox Sanguinis. 2012;103((4):):322-30.
BACKGROUND AND OBJECTIVES There are conflicting data regarding the therapeutic efficacy of platelets inactivated using amotosalen and ultraviolet A light. We have performed a meta-analysis to summarize the results of different randomized controlled trials (RCT). MATERIALS AND METHODS Five RCTs reported through March 2011 met the criteria for meta-analysis. Weighted mean difference (WMD) in corrected count increment (CCI) at 1 h, CCI-24 h, and transfusion interval (days) and summary odds ratio (OR) of bleeding in inactivated platelet (I-P) group vs. noninactivated platelet (C-P) group were calculated across studies. RESULTS Randomized controlled trials were statistically homogeneous when we analysed CCI-24 h, and the transfusion of C-P was associated with a higher CCI-24 h when compared with the transfusion of I-P (WMD, 3x10(3); 95% CI, 2.32x10(3)-3.69x10(3); P<0.00001). RCTs were statistically heterogeneous when we analysed CCI-1 h, transfusion interval and OR of bleeding. Regarding the OR of bleeding in the I-P and C-P groups, it varied by as much as a multiple of four among the trials, from 0.66 to 2.66. When we combined double-blinded and high methodologic quality score RCTs, the use of I-P was not statistically associated with an increase in the OR of bleeding when compared with the use of C-P (OR, 0.97; 95% CI, 0.75-1.27; P=0.84). CONCLUSION Although the transfusion of I-P was associated with lower CCI-24 h when compared with the transfusion of C-P, this was not associated with differences in the OR of bleeding between I-P and C-P. 2012 The Author(s). Vox Sanguinis 2012 International Society of Blood Transfusion.
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
British Journal of Haematology. 2011;153((3):):393-401.
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.
Clinical studies with Intercept treated platelets
Transfusion Medicine. 2010;20((Suppl 1):):7-8.. Abstract No. SI16.
Lower or higher doses for prophylactic platelet transfusions: results of a meta-analysis of randomized controlled trials
BACKGROUND There are conflicting data regarding the optimal platelet (PLT) dose to transfuse prophylactically to patients with thrombocytopenia. A meta-analysis has been performed to summarize the results of different randomized controlled trials (RCTs). STUDY DESIGN AND METHODS RCTs reported through December 2005 were retrieved; five of them met the criteria for meta-analysis. Weighted mean difference (WMD) of posttransfusion PLT count increment (x10(9)/L) and transfusion interval (days) and summary odds ratio (OR) of bleeding in higher PLT dose group (HDP) versus lower PLT dose group (LDP), according to the authors, were calculated across studies. RESULTS The use of HDP was associated with an increase in the transfusion interval (WMD, 1.04 days; 95% confidence interval (CI), 0.89-1.19; p < 0.00001) when compared with the use of LDP. When the studies that guaranteed the ABO compatibility of the PLT transfusions were combined, the use of HDP was statistically associated with an increase in the posttransfusion PLT count increment when compared with the LDP group (WMD, 23.6 x 10(9)/L; 95% CI, 18.28 x 10(9) to 28.92 x 10(9)/L; p < 0.00001). When bleeding was studied, data were available in only three studies and the hypothesis of homogeneity was rejected, in 4 of 10 subgroups analyses. CONCLUSION Few RCTs have addressed the issue of PLT dose for transfusion. It is shown that the transfusion of higher doses of PLTs is statistically associated with an increase in the transfusion interval and in the posttransfusion PLT count increment. A well-designed study of enough power is essential to establish the most effective and efficient dose for prophylactic PLT transfusions.