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

August 4, 2025 updated by: Etablissement Français du Sang

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

"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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Whole blood
Participants in this arm donate whole blood
Biological: Whole blood donation
This intervention involves the collection of a whole blood bag.
Other: Apheresis
Participants in this arm make a plasma/platelet apheresis donation
Biological: Apheresis donation
This procedure involves the collection of a plasma/platelets bag by apheresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the platelet-related inflammatory potential of blood products throughout storage.
Time Frame: Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 21, Day 28, Day 35 and Day 42

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Etablissement Français du Sang

Collaborators

Centre de transfusion sanguine des Armées, Clamart, France
INSERM, SAINBIOSE U1059

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

February 5, 2025

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 241-PEDESTAL EFS
  • 2024-A01405-42 (Other Identifier: ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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