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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Etablissement Français du Sang

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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