Comparison of the Hemostatic Efficacy of Pathogen-Reduced Platelets vs Untreated Platelets in Patients With Thrombocytopenia and Malignant Hematologic Diseases: A Randomized Clinical Trial.

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.

A prospective, active haemovigilance study with combined cohort analysis of 19,175 transfusions of platelet components prepared with amotosalen-UVA photochemical treatment.

Background And Objectives: 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.

Materials And Methods: This open-label, observational haemovigilance programme of PCT-PLT transfusions was conducted in 21 centres in 11 countries.

Plasma transfusion in liver transplantation: a randomized, double-blind, multicenter clinical comparison of three virally secured plasmas.

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.

Impact of leucocyte depletion and prion reduction filters on TSE blood borne transmission.

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.

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.

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.

[Automation in the preparation of labile blood products].

The preparation of labile blood products in a blood bank is in permanent technological progress. Many operations, such as blood centrifugation, components separation, etc. are now performed by automated devices.

[Platelet transfusion: products, indications, dose, threshold and efficacy].

The quality of platelet concentrates had been greatly improved since the implementation of processing techniques based on the use of the buffy-coat in the years 1980. More recently, in the last 10 years, it is in the domain of safety that the greatest advances have been done, by the introduction of platelet additive solutions, on one hand, and by the progressive availability of pathogen reduction techniques, on the other hand. These developments in quality and safety of platelet components are important, as they lead to the conclusion that nowadays, apheresis platelet concentrates and pooled random donor platelet concentrates can be considered as equivalent, the only specific indication of the former being the care of HLA or HPA allo-immunized patients.

[Evolution of techniques for preparation of labile blood products (LBP): pathogen inactivation in LBP].

The techniques for inactivation of pathogens in labile blood products (LBP) would appear to be the new strategy which will permit us to increase transfusion safety in the face of the risks of transmission of pathogenic agents by LBP. Various methods are in the course of development or already validated and used in France. The latter only apply however to plasma or platelet concentrates.

Use of random versus apheresis platelet concentrates.

The respective use of random (RPC) and apheresis (APC) platelet concentrates is highly heterogeneous among countries, ranging from 10 to 98% RPC in countries supposed to provide a similar transfusion service to patients. Moreover, when considering each country in the past 10 years, one can observe that some have changed their policy, switching from a majority of APC to RPC or vice versa. This presentation intends to analyse which factors may impact such decisions.

An active haemovigilance programme characterizing the safety profile of 7437 platelet transfusions prepared with amotosalen photochemical treatment.

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.

[Introduction of platelet additive solutions in transfusion practice. Advantages, disadvantages and benefit for patients].

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.

Corrosion susceptibility of titanium covered by dental cements.

Objectives: The aim of this study is to determine the influence of acidic fluorinated cements (as glass ionomer (GI) cements) on the passivation of titanium, using electrochemical investigations.

Methods: We realized experimental electrodes that associate titanium and dental cements. Polarization resistance of titanium electrodes has been determined for uncovered metal and electrodes covered with three dental cements.

[Discovery of a chronic HVC infection without seroconversion in a blood donor in France during 28 months].

The HCV-RNA screening technique developed by the French Fractionation and Biotechnology Laboratory singled out in March 1998 a case of positive HCV-RNA viremia in a blood donor without any anti-HCV antibody. That donor was a 46-year-old woman who had made 54 donations of blood products from 1988 to 1997. She had no history of blood transfusion, no history of hepatitis and no life-style risk factor.

[Biomechanical study of the vasomotor system of the arterial smooth muscle after long-term cryopreservation of a human arterial graft at two different temperatures -80 and -150C].

We conducted two parallel studies on cryopreserved arterial homografts: a biomechanical study based on traction tests and a functional study coupled with a histology examination. Twenty-four arterial segments from 6 donors (2 iliac and 2 superficial femoral segments per donor) were cryopreserved at -150 degrees C and -80 degrees C. Cryopreservation lasted at least 6 months.

[Evaluation of the cost of autologous erythrocyte concentrates in a hospital].

This study evaluated the cost of autologous and homologous blood products. The cost effectiveness of the transfusion therapy was not evaluated. To compare the different products, the cost of one gram of transfused haemoglobin was calculated.

[Rheologic and cytologic study of autologous blood collected with Cell Saver 4 during cesarean].

Intra-operative autologous transfusion has been frequently used in vascular and traumatic surgery for about ten years. The technique would be justified in other procedures when intra-operative bleeding is significant and the quality of retrieved blood is satisfactory. We have studied the potential use of intra-operative autologous transfusion during caesarean section of 15 parturients.

Prevention of HLA immunization with leukocyte-poor packed red cells and platelet concentrates obtained by filtration.

HLA immunization is a common complication of transfusion therapy in 30% to 60% of oncohematologic patients. Evidence shows that leukocytes present in cellular blood products are the main component involved in the occurrence of HLA immunization, and several studies showed that leukocyte-poor blood products are less able to induce it. However, leukocyte-poor platelet concentrates obtained by conventional techniques, ie, centrifugation, frequently have a high level of remaining leukocytes.

A new method for monitoring the sterility of blood donation.

Sterility of blood products is a cardinal contributor to patient safety. Bacteriologic controls of stable products comply with strict regulations, but legislation imposes only limited constraints in the case of perishable products, such as packed red cells (RBCs) or fresh-frozen plasma (FFP). Therefore, it is essential to monitor the sterility of aseptic donations from uninfected donors.

Standardization of blood product preparation by means of a "centrifugation index".

A centrifugation index for blood product preparation is proposed. This index, calculated from the domain of ultracentrifugation, is most applicable to describe the effects of centrifugation of large volumes than the relative centrifugal force and centrifugation time commonly used. The value of such an index is illustrated by the calculation of the minimum centrifugation time required for the preparation of platelet-poor plasma with seven different centrifuges.