grouP O wholE blooD : storagE leSion impacT And infLammation
PEDESTAL EFS
grouP O wholE blooD (LTO-WB): storagE leSion impacT And infLammation
2 other identifiers
interventional
30
1 country
1
Brief Summary
"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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2025
CompletedFirst Posted
Study publicly available on registry
February 5, 2025
CompletedStudy Start
First participant enrolled
March 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
August 6, 2025
August 1, 2025
2.9 years
January 8, 2025
August 4, 2025
Conditions
Keywords
Outcome Measures
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.
Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 21, Day 28, Day 35 and Day 42
Study Arms (2)
Whole blood
OTHERParticipants in this arm donate whole blood
Apheresis
OTHERParticipants in this arm make a plasma/platelet apheresis donation
Interventions
This intervention involves the collection of a whole blood bag.
This procedure involves the collection of a plasma/platelets bag by apheresis
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Subjects ineligible to donate blood
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Etablissement Français du Sanglead
- Centre de transfusion sanguine des Armées, Clamart, Francecollaborator
- INSERM, SAINBIOSE U1059collaborator
Study Sites (1)
Maison du don de l'EFS Auvergne Rhônes-Alpes
Saint-Etienne, 42100, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2025
First Posted
February 5, 2025
Study Start
March 12, 2025
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
August 6, 2025
Record last verified: 2025-08