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1.
JAMA Oncol ; 4(4): 468-475, 2018 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-29392283

RESUMO

IMPORTANCE: Pathogen reduction of platelet concentrates may reduce transfusion-transmitted infections but is associated with qualitative impairment, which could have clinical significance with regard to platelet hemostatic capacity. OBJECTIVE: To compare the effectiveness of platelets in additive solution treated with amotosalen-UV-A vs untreated platelets in plasma or in additive solution in patients with thrombocytopenia and hematologic malignancies. DESIGN, SETTING, AND PARTICIPANTS: The Evaluation of the Efficacy of Platelets Treated With Pathogen Reduction Process (EFFIPAP) study was a randomized, noninferiority, 3-arm clinical trial performed from May 16, 2013, through January 21, 2016, at 13 French tertiary university hospitals. Clinical signs of bleeding were assessed daily until the end of aplasia, transfer to another department, need for a specific platelet product, or 30 days after enrollment. Consecutive adult patients with bone marrow aplasia, expected hospital stay of more than 10 days, and expected need of platelet transfusions were included. INTERVENTIONS: At least 1 transfusion of platelets in additive solution with amotosalen-UV-A treatment, in plasma, or in additive solution. MAIN OUTCOMES AND MEASURES: The proportion of patients with grade 2 or higher bleeding as defined by World Health Organization criteria. RESULTS: Among 790 evaluable patients (mean [SD] age, 55 [13.4] years; 458 men [58.0%]), the primary end point was observed in 126 receiving pathogen-reduced platelets in additive solution (47.9%; 95% CI, 41.9%-54.0%), 114 receiving platelets in plasma (43.5%; 95% CI, 37.5%-49.5%), and 120 receiving platelets in additive solution (45.3%; 95% CI, 39.3%-51.3%). With a per-protocol population with a prespecified margin of 12.5%, noninferiority was not achieved when pathogen-reduced platelets in additive solution were compared with platelets in plasma (4.4%; 95% CI, -4.1% to 12.9%) but was achieved when the pathogen-reduced platelets were compared with platelets in additive solution (2.6%; 95% CI, -5.9% to 11.1%). The proportion of patients with grade 3 or 4 bleeding was not different among treatment arms. CONCLUSIONS AND RELEVANCE: Although the hemostatic efficacy of pathogen-reduced platelets in thrombopenic patients with hematologic malignancies was noninferior to platelets in additive solution, such noninferiority was not achieved when comparing pathogen-reduced platelets with platelets in plasma. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01789762.


Assuntos
Plaquetas/citologia , Transmissão de Doença Infecciosa/prevenção & controle , Doenças Hematológicas/terapia , Transfusão de Plaquetas/métodos , Trombocitopenia/terapia , Adulto , Idoso , Segurança do Sangue/métodos , Desinfecção/métodos , Estudos de Equivalência como Asunto , Feminino , França , Hemostasia/fisiologia , Hemostáticos/uso terapêutico , Hospitais Universitários , Humanos , Masculino , Pessoa de Meia-Idade
2.
Transfusion ; 53(6): 1335-45, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22998014

RESUMO

BACKGROUND: The clinical equivalence of plasma treated to reduce pathogen transmission and untreated plasma has not been extensively studied. A clinical trial was conducted in liver transplant recipients to compare the efficacy of three plasmas. STUDY DESIGN AND METHODS: A randomized, equivalence, blinded trial was performed in four French liver transplantation centers. The three studied (fresh-frozen) plasmas were quarantine (Q-FFP), methylene blue (MB-FFP), and solvent/detergent (S/D-FFP) plasmas. The primary outcome was the volume of plasma transfused during transplantation. Secondary outcomes included intraoperative blood loss, hemostasis variables corrections, and adverse events. RESULTS: One-hundred patients were randomly assigned in the MB-FFP, 96 in the S/D-FFP, and 97 in the Q-FFP groups, respectively. The median volumes of plasma transfused were 2254, 1905, and 1798 mL with MB-FFP, S/D-FFP, and Q-FFP, respectively. The three plasmas were not equivalent. MB-FFP was not equivalent to the two other plasmas, but S/D-FFP and Q-FFP were equivalent. The median numbers of transfused plasma units were 10, 10, and 8 units with MB-FFP, S/D-FFP, and Q-FFP, respectively. Adjustment on bleeding risk factors diminished the difference between groups: the excess plasma volume transfused with MB-FFP compared to Q-FFP was reduced from 24% to 14%. Blood loss and coagulation factors corrections were not significantly different between the three arms. CONCLUSION: Compared to both Q-FFP and S/D-FFP, use of MB-FFP was associated with a moderate increase in volume transfused, partly explained by a difference in unit volume and bleeding risk factors. Q-FFP was associated with fewer units transfused than either S/D-FFP or MB-FFP.


Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Hemostasia , Transplante de Fígado , Plasma , Complicações Pós-Operatórias/prevenção & controle , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Detergentes , Método Duplo-Cego , Inibidores Enzimáticos , Feminino , Humanos , Modelos Lineares , Hepatopatias/epidemiologia , Hepatopatias/cirurgia , Masculino , Azul de Metileno , Pessoa de Meia-Idade , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/epidemiologia , Quarentena , Fatores de Risco , Solventes , Resultado do Tratamento , Viroses/prevenção & controle
3.
PLoS One ; 7(7): e42019, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22860049

RESUMO

The identification in the UK of 4 v-CJD infected patients thought to be due to the use of transfused Red Blood Cell units prepared from blood of donors incubating v-CJD raised major concerns in transfusion medicine. The demonstration of leucocyte associated infectivity using various animal models of TSE infection led to the implementation of systematic leuco-depletion (LD) of Red Blood cells concentrates (RBCs) in a number of countries. In the same models, plasma also demonstrated a significant level of infectivity which raised questions on the impact of LD on the v-CJD transmission risk. The recent development of filters combining LD and the capture of non-leucocyte associated prion infectivity meant a comparison of the benefits of LD alone versus LD/prion-reduction filters (LD/PR) on blood-borne TSE transmission could be made. Due to the similarity of blood/plasma volumes to human transfusion medicine an experimental TSE sheep model was used to characterize the abilities of whole blood, RBCs, plasma and buffy-coat to transmit the disease through the transfusion route. The impact of a standard RBCs LD filter and of two different RBCs LD/PR prototype filters on the disease transmission was then measured. Homologous recipients transfused with whole-blood, buffy-coat and RBCs developed the disease with 100% efficiency. Conversely, plasma, when intravenously administered resulted in an inconstant infection of the recipients and no disease transmission was observed in sheep that received cryo-precipitated fraction or supernatant obtained from infectious plasma. Despite their high efficacy, LD and LD/PR filtration of the Red Blood Cells concentrate did not provide absolute protection from infection. These results support the view that leuco-depletion strongly mitigates the v-CJD blood borne transmission risk and provide information about the relative benefits of prion reduction filters.


Assuntos
Patógenos Transmitidos pelo Sangue , Procedimentos de Redução de Leucócitos , Doenças Priônicas/transmissão , Príons/isolamento & purificação , Animais , Western Blotting , Imuno-Histoquímica , Ovinos
4.
Br J Haematol ; 153(3): 393-401, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21418180

RESUMO

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.


Assuntos
Plaquetas/efeitos dos fármacos , Preservação de Sangue/métodos , Transfusão de Plaquetas/métodos , Raios Ultravioleta , Adolescente , Adulto , Idoso , Plaquetas/microbiologia , Plaquetas/efeitos da radiação , Senescência Celular , Método Duplo-Cego , Transfusão de Eritrócitos , Feminino , Furocumarinas/farmacologia , Hemostasia , Humanos , Masculino , Viabilidade Microbiana , Pessoa de Meia-Idade , Contagem de Plaquetas , Transfusão de Plaquetas/efeitos adversos , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
5.
Transfus Clin Biol ; 14(1): 100-6, 2007 May.
Artigo em Francês | MEDLINE | ID: mdl-17524696

RESUMO

Platelet additive solutions (PAS) have been developed since the years 1980. However, decisive improvements have been made in the last five years, leading nowadays to several PAS available for transfusion practice. Few compounds are present in PAS, with the intention of controlling platelet metabolic alterations and activation that occur during storage: acetate, which is a substrate for the tricarboxylic acid cycle, enables to maintain oxidative metabolism, is present in all PAS; a buffer effect is required to prevent the progressive pH fall during storage, and is obtained either with sodium phosphate or gluconate; platelet activation is controlled by citrate, and in the latest PAS, by magnesium and potassium. It is important to note that whatever the PAS used, it is mandatory to maintain a final concentration of 20-40% of plasma, mainly in order to ensure glucose availability. The use of PAS leads to a more rationalized blood processing, as it provides an additional volume of plasma available for plasma fractionation, it contributes to standardization of blood components, and it is part of at least one pathogen reduction process. The expected benefit for patient is the reduction of adverse reactions related to plasma. There is already evidence that the incidence of allergic adverse reactions is reduced. In the case of other less frequent adverse reactions such as transfusion related acute lung injury (TRALI) or haemolytic reaction due to minor ABO incompatibility, only a long-term follow-up through haemovigilance organization will be informative.


Assuntos
Transfusão de Plaquetas/métodos , Soluções , Acetatos/sangue , Glicemia/metabolismo , Preservação de Sangue/métodos , Citratos/sangue , Humanos , Magnésio/sangue , Fosfatos/sangue , Transfusão de Plaquetas/efeitos adversos , Potássio/sangue , Conservantes Farmacêuticos , Resultado do Tratamento
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