NCT06809010

grouP O wholE blooD : storagE leSion impacT And infLammation

grouP O wholE blooD (LTO-WB): storagE leSion impacT And infLammation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Etablissement Français du Sang · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Blood Donation
• Blood Platelets
• Blood Donors
• Inflammation
• Transfusion

Interventions

Type	Name	Description
BIOLOGICAL	Whole blood donation	This intervention involves the collection of a whole blood bag.
BIOLOGICAL	Apheresis donation	This procedure involves the collection of a plasma/platelets bag by apheresis

Timeline

• Start date: 2025-03-12
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2025-02-05
• Last updated: 2025-08-06

Locations

1 site across 1 country: France