grouP O wholE blooD : storagE leSion impacT And infLammation (PEDESTAL EFS)

Etablissement Français du Sang

Status: Enrolling

Conditions: Inflammation; Blood Donation; Blood Donors; Blood Platelets; Transfusion

Treatments: Biological: Whole blood donation; Biological: Apheresis donation

Study type: Interventional

Funder types: Other

Identifiers

NCT06809010

2024-A01405-42 (Other Identifier)

241-PEDESTAL EFS

Details and patient eligibility

About

"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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Whole blood

Other group

Description:

Participants in this arm donate whole blood

Treatment:

Biological: Whole blood donation

Apheresis

Other group

Description:

Participants in this arm make a plasma/platelet apheresis donation

Treatment:

Biological: Apheresis donation