Clinical trial NCT06809010: GrouP O WholE BlooD : StoragE LeSion ImpacT and InfLammation
Official title: GrouP O WholE BlooD (LTO-WB): StoragE LeSion ImpacT and InfLammation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Blood Donation
Blood Platelets
Blood Donors
Inflammation
Transfusion
Keywords: blood
LTO-WB
characterization of labile blood products
whole blood
apheresis
plasma
platelet
red blood cells
inflammation
transfusion
Lead sponsor: Etablissement Français du Sang
Sponsor class: OTHER
Collaborators: name: Centre de transfusion sanguine des Armées, Clamart, France
name: INSERM, SAINBIOSE U1059
First posted: 2025-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first 15 participants will be whole blood donations and the next 15 apheresis donations. Working sequentially on whole blood donations (n=15) followed by apheresis donations (n=15) will enable us to evaluate the biological markers of interest on whole blood donations and not repeat these experiments on apheresis platelet donations, which are rarer and longer.
Primary purpose: BASIC_SCIENCE

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Self-referred donors eligible for blood donation (whole blood and/or platelet/plasma apheresis), meeting the following inclusion criteria:

* 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.

Exclusion Criteria:

Subjects ineligible to donate blood

Primary outcomes:
measure: Assessment of the platelet-related inflammatory potential of blood products throughout storage.
timeFrame: Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 21, Day 28, Day 35 and Day 42
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Maison du don de l'EFS Auvergne Rhônes-Alpes
Study officials:
References: