"Etablissement Français du Sang" (EFS) prepares labile blood products from blood donations that are separated by type (red blood cells, plasma and platelets). The "Centre de Transfusion Sanguine des Armées" (CTSA) produces an innovative labile blood product, LTO-WB, corresponding to group O leukocyte-free whole blood. The objective of the PEDESTAL EFS study is to compare the inflammatory and biological characteristics of blood products prepared by the EFS vs. the labile blood product prepared by the CTSA.
Hemorrhage is one of the main causes of preventable death among soldiers in combat. Currently, the majority of patients receive blood components (red blood cells, platelets, plasma) rather than whole blood. These factors lead doctors deployed on external operations (OPEX) to use plasma, RBCs and platelets. However, platelet concentrates may not be available on missions, as their storage conditions and shelf life are not always compatible with OPEX logistics. The only solutions to this problem is to use group O leucocyte-depleted whole blood without hemolysin (or Low Titer O Whole Blood, LTOWB), which provides the three elements in physiological proportions. However, while studies have shown this product to be effective in stopping bleeding, its inflammatory potential, linked to the presence of platelets, has not yet been investigated. Indeed, in addition to their hemostatic role, platelets are also involved in inflammation. The main objective of our research project is to deploy in vitro and in vivo tools to compare LTOWB, focusing on its inflammatory component with conventional and well-mastered transfusion products for (1) platelet-related inflammation (LTOWB vs. Buffy coat pooled platelet concentrate or single donor apheresis platelet concentrates), (2) RBC-related inflammation (LTOWB vs. RBC concentrates) and (3) other circulating inflammatory molecules (LTOWB vs. fresh frozen plasma). The definition of biomarkers is essential to optimize the use of these products, depending on the therapeutic indication. Linking these biomarkers with the effectiveness of transfusions will help to determine the risk/benefit ratio of transfusions that may be required in rural and austere environments, such as OPEX in comparison to civilian transfusion medicine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
This intervention involves the collection of a whole blood bag.
This procedure involves the collection of a plasma/platelets bag by apheresis
Maison du don de l'EFS Auvergne Rhônes-Alpes
Saint-Etienne, France
RECRUITINGAssessment of the platelet-related inflammatory potential of blood products throughout storage.
Assessment of the platelet-related inflammatory potential throughout storage, including the concentration of platelet-related soluble immunomodulatory molecules and the cellular expression of activation markers, which characterize the quality of labile blood products, notably apheresis platelet concentrates, standard Buffy coat pooled platelet concentrate, red blood cell concentrates and fresh plasma prepared by EFS, compared to platelet, red blood cells and plasmas from LTO-WB. Several techniques will be used to this purpose, including ELISA, Luminex multi-analyte profiling for soluble immunomodulatory molecule assessment and flow cytometry for activation marker cellular expression.
Time frame: Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 21, Day 28, Day 35 and Day 42
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