grouP O wholE blooD : storagE leSion impacT And infLammation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEtablissement Français du Sang
About this trial
"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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Be in good health
Weigh at least 50 kg
Must be between 18 and 70 years of age for whole blood donation and between 18 and 65 years of age for plasma/platelet donation by apheresis.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Whole blood donation
Biological/VaccineThis intervention involves the collection of a whole blood bag.
Apheresis donation
Biological/VaccineThis procedure involves the collection of a plasma/platelets bag by apheresis
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Whole bloodOther 1 intervention
Group B: ApheresisOther 1 intervention
Trial outcomes
Primary outcomes
1
Assessment 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 42Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Etablissement Français du Sang
Lead sponsor
Centre de transfusion sanguine des Armées, Clamart, France
Collaborator
INSERM, SAINBIOSE U1059
Collaborator
Source ClinicalTrials.gov