Editor's Choice
Transfusion. 2024 Mar;64(3):457-465 doi: 10.1111/trf.17720.
POPULATION:
Participants with hypoproliferative thrombocytopenia requiring platelet transfusions, enrolled in the MiPLATE trial (n= 297). INTERVENTION:Mirasol-treated plasma-stored apheresis platelets (Mirasol group, n= 145). COMPARISON:Conventional plasma-stored apheresis platelets (Control group, n= 152). OUTCOME:The novel primary endpoint was days of ≥Grade 2 bleeding with a non-inferiority margin of 1.6. Participants in the Mirasol group had more days of grade ≥2 bleeding than participants in the Control group (RR 2.74; 95% CI [1.66, 4.53]), the primary endpoint. The secondary endpoints showed a similar proportion of participants in each group with days of grade ≥2 bleeding and no difference in red blood cell transfusion despite a higher rate of participants with platelets refractoriness, platelet transfusions, and lower corrected count increments in the Mirasol group.
BACKGROUND:
The Mirasol® Pathogen Reduction Technology System was developed to reduce transfusion-transmitted diseases in platelet (PLT) products. STUDY DESIGN AND METHODS:MiPLATE trial was a prospective, multicenter, controlled, randomized, non-inferiority (NI) study of the clinical effectiveness of conventional versus Mirasol-treated Apheresis PLTs in participants with hypoproliferative thrombocytopenia. The novel primary endpoint was days of ≥Grade 2 bleeding with an NI margin of 1.6. RESULTS:After 330 participants were randomized, a planned interim analysis of 297 participants (145 MIRASOL, 152 CONTROL) receiving ≥1 study transfusion found a 2.79-relative rate (RR) in the MIRASOL compared to the CONTROL in number of days with ≥Grade 2 bleeding (95% confidence interval [CI] 1.67-4.67). The proportion of subjects with ≥Grade 2 bleeding was 40.0% (n = 58) in MIRASOL and 30.3% (n = 46) in CONTROL (RR = 1.32, 95% CI 0.97-1.81, p = .08). Corrected count increments were lower (p < .01) and the number of PLT transfusion episodes per participant was higher (RR = 1.22, 95% CI 1.05-1.41) in MIRASOL. There was no difference in the days of PLT support (hazard ratio = 0.86, 95% CI 0.68-1.08) or total number of red blood cell transfusions (RR = 1.12, 95% CI 0.91-1.37) between MIRASOL versus CONTROL. Transfusion emergent adverse events were reported in 119 MIRASOL participants (84.4%) compared to 133 (82.6%) participants in CONTROL (p = NS). DISCUSSION:This study did not support that MIRASOL was non-inferior compared to conventional platelets using the novel endpoint number of days with ≥Grade 2 bleeding in MIRASOL when compared to CONTROL. |
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Editor's Choice
Transfusion. 2024 Feb;64(2):289-300 doi: 10.1111/trf.17688.
POPULATION:
Adult and paediatric patients, as well as general and specific clinical populations (80 studies). INTERVENTION:Systematic review and meta-analysis to estimate the incidence of transfusion-related acute lung injury (TRALI) by blood component, using active surveillance and modern donor risk mitigation strategies implemented for plasma and platelets. COMPARISON: OUTCOME:The included studies reported approximately 176-million blood components transfused. Red blood cells (RBCs) had the highest number of studies (n= 66) included, followed by platelets (n= 35) and plasma (n= 34). Pooled TRALI estimates for active surveillance studies were 0.17/10,000; 95% confidence intervals (CI) [0.03, 0.43]; I(2)= 79%) for RBCs, 0.31/10,000; 95% CI [0.22, 0.42]; I(2)= <1%) for platelets, and 3.19/10,000; 95% CI [0.09, 10.66]; I(2)= 86% for plasma. Studies using passive surveillance ranged from 0.02 to 0.10/10,000 among the various blood components.
BACKGROUND:
Transfusion-related acute lung injury (TRALI) is a leading cause of transfusion-related mortality. A concern with passive surveillance to detect transfusion reactions is underreporting. Our aim was to obtain evidence-based estimates of TRALI incidence using meta-analysis of active surveillance studies and to compare these estimates with passive surveillance. STUDY DESIGN AND METHODS:We performed a systematic review and meta-analysis of studies reporting TRALI rates. A search of Medline and Embase by a research librarian identified studies published between January 1, 1991 and January 20, 2023. Prospective and retrospective observational studies reporting TRALI by blood component (red blood cells [RBCs], platelets, or plasma) were identified and all inpatient and outpatient settings were eligible. Adult and pediatric, as well as general and specific clinical populations, were included. Platelets and plasma must have used at least one modern TRALI donor risk mitigation strategy. A random effects model estimated TRALI incidence by blood component for active and passive surveillance studies and heterogeneity was examined using meta-regression. RESULTS:Eighty studies were included with approximately 176-million blood components transfused. RBCs had the highest number of studies (n = 66) included, followed by platelets (n = 35) and plasma (n = 34). Pooled TRALI estimates for active surveillance studies were 0.17/10,000 (95% confidence intervals [CI]: 0.03-0.43; I2 = 79%) for RBCs, 0.31/10,000 (95% CI: 0.22-0.42; I2 = <1%) for platelets, and 3.19/10,000 (95% CI: 0.09-10.66; I2 = 86%) for plasma. Studies using passive surveillance ranged from 0.02 to 0.10/10,000 among the various blood components. DISCUSSION:In summary, these estimates may improve a quantitative understanding of TRALI risk, which is important for clinical decision-making weighing the risks and benefits of transfusion. |
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Editor's Choice
Transpl Immunol. 2023 Jun;78:101801 doi: 10.1016/j.trim.2023.101801.
POPULATION:
Kidney transplant recipients (11 studies, n= 19,543). INTERVENTION:Kidney transplantation with blood transfusion (n= 6,191). COMPARISON:Kidney transplantation without blood transfusion (n= 13,352). OUTCOME:The authors assessed the pooled associations between blood transfusion and occurrence of de novo donor-specific antibodies (dnDSA) and clinical outcomes. Blood transfusion was strongly correlated with the development of dnDSA (relative risk (RR) 1.40; 95% confidence interval (CI) [1.17, 1.67]). Patients with blood transfusion had a higher risk of developing anti-human leukocyte antigen (HLA) class I dnDSA than non-transfused patients (RR 1.75; 95% CI [1.14, 2.69]) as well as significantly higher rates of antibody-mediated rejection (RR 1.41; 95% CI [1.21, 2.35]) and graft loss (RR 1.75; 95% CI [1.30, 2.35]). There were no statistically significant differences between the two groups in the development of anti-HLA antibodies, anti-HLA class II dnDSA, and anti-HLA class I and II dnDSA; delayed graft function; T cell-mediated rejection; acute rejection; borderline rejection; or patient death. The relationship between blood transfusion following kidney transplantation (KT) and the development of de novo donor-specific antibodies (dnDSA) is controversial. This was investigated by conducting a meta-analysis of studies on patients who underwent KT with or without blood transfusion, and by evaluating the effect of post-KT blood transfusion on clinical outcomes of kidney transplant recipients. Relevant studies in the PubMed, EMBASE, and Cochrane Library databases were identified from inception to July 1, 2022. Two reviewers independently extracted data from the selected articles and estimated study quality. A fixed effects or random effects model was used to pool data according to the heterogeneity among studies. Data included in the meta-analysis were derived from 11 studies with a total of 19,543 patients including 6191 with and 13,352 without blood transfusion post-KT. We assessed the pooled associations between blood transfusion and occurrence of dnDSA and clinical outcomes of transplant recipients. Blood transfusion was strongly correlated with the development of dnDSA (relative risk [RR] = 1.40, 95% confidence interval [CI]: 1.17-1.67; P < 0.05). Patients with blood transfusion had a higher risk of developing anti-human leukocyte antigen (HLA) class I dnDSA than non-transfused patients (RR = 1.75, 95% CI: 1.14-2.69; P < 0.05) as well as significantly higher rates of antibody-mediated rejection (AMR) (RR = 1.41, 95% CI: 1.21-2.35; P < 0.05) and graft loss (RR = 1.75, 95% CI: 1.30-2.35; P < 0.05). There were no statistically significant differences between the two groups in the development of anti-HLA antibodies, anti-HLA class II dnDSA, and anti-HLA class I and II dnDSA; delayed graft function; T cell-mediated rejection; acute rejection; borderline rejection; or patient death. Our results suggest that blood transfusion was associated with dnDSA development in KT recipients. The findings of this systematic review also suggest that post-KT blood transfusion recipients have a higher risk of AMR, and graft loss compared with non-transfused patients. Evidence from this meta-analysis indicates that the use of blood transfusion post-KT is associated with a significantly higher risk of immunological sensitization. More and higher quality results from large randomized controlled trials are still needed to inform clinical practice. |