Therapeutic efficacy and safety of photochemically treated apheresis platelets processed with an optimized integrated set (original) (raw)
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Vox sanguinis, 2015
A photochemical treatment process (PCT) utilizing amotosalen and UVA light (INTERCEPT(™) Blood System) has been developed for inactivation of viruses, bacteria, parasites and leucocytes that can contaminate blood components intended for transfusion. The objective of this study was to further characterize the safety profile of INTERCEPT-treated platelet components (PCT-PLT) administered across a broad patient population. This open-label, observational haemovigilance programme of PCT-PLT transfusions was conducted in 21 centres in 11 countries. All transfusions were monitored for adverse events within 24 h post-transfusion and for serious adverse events (SAEs) up to 7 days post-transfusion. All adverse events were assessed for severity (Grade 0-4), and causal relationship to PCT-PLT transfusion. Over the course of 7 years in the study centres, 4067 patients received 19 175 PCT-PLT transfusions. Adverse events were infrequent, and most were of Grade 1 severity. On a per-transfusion bas...
Vox Sanguinis, 2008
Background An active haemovigilance programme was implemented to survey adverse events (AE) associated with transfusion of platelets photochemically treated with amotosalen and ultraviolet A (PCT-PLT). The results of 5106 transfusions have already been reported. Here we report the results of an additional 7437 PCT-PLT transfusions.Methods The focus of this ongoing haemovigilance programme is to document all AEs associated with PCT-PLT transfusion. Data collected for AEs include: time of event after starting transfusion, clinical descriptions, vital signs, results from radiographs and bacterial cultures, event severity (Grade 0–4) and causal relationship to PCT-PLT transfusion.Results One thousand four hundred patients (mean 60 years, range 1–96) received PCT-PLT transfusions. The majority of the patients (53·4%) had haematology–oncology diseases and required conventional chemotherapy (44·8%) or stem cell transplantation (8·6%). Sixty-eight PCT-PLT transfusions were associated with AE. Acute transfusion reactions (ATR), classified as an AE possibly related, probably related, or related to PCT-PLT transfusions were infrequent (n = 55, 55/7437 = 0·7%) and most were of Grade 1 severity. Thirty-nine patients (39/1400 = 2·8%) experienced one or more ATRs. The most frequently reported signs/symptoms were chills, fever, urticaria, dyspnoea, nausea and vomiting. Five AEs were considered severe (≥ Grade 2); however, no causal relationship to PCT-PLT transfusion was found. Repeated exposure to PCT-PLT did not increase the likelihood of an ATR. No cases of transfusion-related acute lung injury and no deaths due to PCT-PLT transfusions were reported.Conclusions Routine transfusion of PCT-PLT is well-tolerated in a wide range of patients. ATRs related to PCT-PLT transfusion were infrequent and most were of mild severity.
Transfusion, 2008
BACKGROUND: Inactivation of pathogens and white blood cells in platelet (PLT) components with amotosalen and UVA light (INTERCEPT, Cerus Europe BV) has entered clinical practice in European blood centers. A prospective cohort study was implemented to characterize the safety profile of this new PLT component in a broad patient population. STUDY DESIGN AND METHODS: Apheresis or buffycoat PLT components were leukoreduced, suspended in approximately 35 percent plasma and 65 percent PLT additive solution, and treated with the INTERCEPT process. Blood centers were requested to complete a safety data form after each transfusion. RESULTS: Data for 5106 INTERCEPT components administered to 651 patients were monitored. A total of 5051 (98.9%) transfusions and 609 (93.5%) patients had no reported reactions. Fifty-five (1.1%) transfusions were associated with adverse events, and 42 (0.8%) were possibly, probably, or related to the PLT transfusion. Adverse events occurred in 42 (6.4%) patients, but in only 32 (4.9%) patients was a causal relationship to PLT transfusion established. One reaction was serious, and no deaths were related to PLT transfusion. Among the transfusions reactions, the most frequent clinical events in descending frequency were chills, fever, dermatologic reactions, dyspnea, nausea or vomiting, and hypotension. No episodes of transfusionrelated acute lung injury were reported. CONCLUSIONS: In this cohort study, 99.2 percent of transfusions were without reactions attributed to PLTs. INTERCEPT PLTs exhibited a safety profile similar to that previously reported for conventional PLT components.
Clinical impact of amotosalen‐ultraviolet A pathogen‐inactivated platelets stored for up to 7 days
Transfusion, 2019
BACKGROUND: Universal pathogen inactivation of platelet concentrates (PCs) using amotosalen/ultraviolet A with 7-day storage was implemented in Switzerland in 2011. Routine-use data were analyzed at the University Hospital Basel, Switzerland. STUDY DESIGN: A retrospective two-cohort study of patient and PC characteristics, component usage, patient outcomes, count increments (CIs), and adverse events were analyzed for two consecutive 5-year periods with either 0-to 5-day-old conventional PC (C-PC) (n = 14,181) or 0-to 7-day-old pathogen-inactivated PC (PI-PC) (n = 22,579). RESULTS: In both periods, PCs were issued for transfusion on a "first in, first out" basis. With 7-day PI-PC, wastage was reduced from 8.7% to 1.5%; 16.6% of transfused PI-PCs were more than 5 days old. Transfusion of PI-PC more than 5 days old compared with 5 days old or less did not increase platelet and RBC use on the same or next day as an indirect measure of hemostasis and did not increase transfusion reactions. Mean corrected count increments (CCIs) for PI-PC stored for 5 days or less were 22.6% lower than for C-PC (p < 0.001), and declined with increasing storage duration for both, although the correlation was weak (r 2 = 0.005-0.014). Mean number of PCs used per patient and duration of PC support were not different for hematology/oncology, allogeneic and autologous hematopoietic stem cell transplant (HSCT), and general medical/surgical patients, who used the majority (~92.0%) of PI-PCs. Five-year treatment-related mortality in allogeneic HSCT was unchanged in the PI-PC period. CONCLUSIONS: PI-PCs with 7-day storage reduced wastage and did not increase PC or red blood cell utilization or adverse reactions compared with fresh PI-PC or a historical control group, demonstrating preserved efficacy and safety.
Infusionstherapie Und Transfusionsmedizin, 1998
BACKGROUND: A photochemical treatment (PCT) process utilizing amotosalen hydrochloride and long wavelength UVA light has been developed to inactivate pathogens in PLTs. This study investigated the effects of amotosalen/UVA treatment on free and latent murine CMV (MCMV) in PLT preparations using a murine model of transfusion-transmitted CMV (TT-CMV). STUDY DESIGN AND METHODS: In a model of latent MCMV infection, "donor" mice received 1 ¥ 10 6 plaqueforming units (PFUs) MCMV and were rested 14 days. Subsequently harvested, pooled, and washed WBCs were PCR positive for MCMV. Murine WBC doses of 1 ¥ 10 4 , 1 ¥ 10 5 , and 1 ¥ 10 6 were added to human apheresis PLTs in 35 percent autologous plasma and 65 percent PLT AS (PAS). The WBC-PLT products were treated with 150 mmol/L amotosalen and 0.6 J per cm 2 UVA and transfused via tail vein injection into recipient mice. Recipients were killed on Day 14. Blood and spleens were collected and assayed for MCMV by PCR. In a parallel model of active infection with free virus, human PLT in 35 percent autologous plasma and 65 percent PAS were dosed with 1 ¥ 10 5 and 1 ¥ 10 6 PFUs of MCMV. All other procedures were as described above. RESULTS: In the absence of amotosalen/UVApretreatment, transfusion of PLT latently or actively infected with MCMV produced TT-CMV in a dosedependent fashion. In contrast, all transfusion recipients of identical PLT preparations pretreated with amotosalen/ UVA were uniformly PCR negative for MCMV (abrogation of TT-CMV; p < 0.05). CONCLUSIONS: PCT of PLT preparations with the specified doses of amotosalen hydrochloride and UVA light prevents transfusion transmission of free and latent MCMV in a murine model. These results suggest that PCT of human PLTs with amotosalen/UVA should also effectively abrogate TT-CMV in the clinical setting.
Transfusion, 2010
Clinical effect of platelet (PLT) transfusion is monitored by measures of PLT viability (PLT recovery and survival) and functionality. In this study we evaluate and compare transfusion effect measures in patients with chemotherapy-induced thrombocytopenia due to treatment of acute leukemia. Forty transfusions (28 conventional gamma-irradiated and 12 pathogen-inactivated photochemical-treated PLT concentrates [PCs]) were investigated. PC quality was analyzed immediately before transfusion. Samples were collected from thrombocytopenic patients at 1 and 24 hours for PLT increments and thromboelastography (TEG) with assessments of bleeding score and intertransfusion interval (ITI). Data were analyzed by Spearman&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s correlation. Patient and PC variables influencing the effect of transfusion were analyzed by use of a mixed-effects model. PLT dose, storage time, and pathogen inactivation correlated with PLT recovery but not with PLT survival (including ITI), TEG, or clinical bleeding. Fever was negatively correlated with PLT survival but did not affect PLT recovery. After 1 and 24 hours, strong correlations were observed within measures of PLT viability and between PLT increment and the TEG value maximal amplitude (MA). Negative correlation was observed between late MA increment and clinical bleeding status after transfusion (r = -0.494, p = 0.008). PLT count increments did not correlate to clinical bleeding status. PLT dose and quality of PCs are important for optimal immediate transfusion response, whereas duration of transfusion effect is influenced mainly by patient variables. The TEG value MA correlates with PLT count increments and bleeding, thus reflecting both PLT viability and functionality.
Blood, 2005
We performed a prospective, randomized, open, blinded end point (PROBE) study to assess the efficiency of transfusing high doses of platelets in patients with thrombocytopenia, either acute leukemia (AL) or those undergoing autologous hematopoietic stem cell transplantation (AT). Patients were randomly assigned to receive transfusions with a target dose of 0.5 × 1011/10 kg (arm A) or 1 × 1011/10 kg (arm B). A total of 101 patients were included, of whom 96 were given at least one transfusion. The median time between the first transfusion and when the platelet count reached at least 20 × 109/L increased from 63 hours to 95 hours in the arm B group (P = .001), and the median number of transfusions was lower in this group (2; P = .037). The total number of transfused platelets did not differ between groups (14.9 × 1011 for arm A versus 18.5 × 1011 for arm B; P = .156). In such patients, a prophylactic strategy of high doses of platelets could improve platelet transfusion efficiency.