Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06809010

Group O Whole Blood (LTO-WB): Storage Lesion Impact and Inflammation

Led by Etablissement Français du Sang · Updated on 2025-08-06

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

E

Etablissement Français du Sang

Lead Sponsor

C

Centre de transfusion sanguine des Armées, Clamart, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the inflammatory and biological characteristics of blood products prepared by two different organizations: the Etablissement Français du Sang (EFS), which produces standard blood components like red blood cells, plasma, and platelets, and the Centre de Transfusion Sanguine des Armées (CTSA), which produces an innovative group O leukocyte-free whole blood product called LTO-WB. This research is important because hemorrhage is a major cause of preventable death in combat, and current blood component supplies may not always be available or suitable in military operations. The study compares LTO-WB with conventional blood products including platelet concentrates, red blood cell concentrates, and fresh frozen plasma, focusing on inflammation related to platelets and red blood cells. Participants donate either whole blood or plasma/platelet products via apheresis. These donations are analyzed over time to assess inflammatory markers and biological changes during storage. Participants will be involved in blood donation procedures and subsequent laboratory analyses will measure inflammatory potential related to platelets at multiple time points during storage, from Day 2 through Day 42. The study aims to identify biomarkers that can optimize transfusion use in both military and civilian settings. This research is sponsored by Etablissement Français du Sang and includes healthy volunteer blood donors aged 18 to 70 for whole blood and 18 to 65 for apheresis donations.

CONDITIONS

Brief Title

grouP O wholE blooD : storagE leSion impacT And infLammation

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Self-referred donors eligible for blood donation (whole blood and/or plasma/platelet apheresis)
  • Be in good health
  • Weigh at least 50 kg
  • Be between 18 and 70 years old for whole blood donation
  • Be between 18 and 65 years old for plasma or platelet donation by apheresis
Not Eligible

You will not qualify if you...

  • Subjects ineligible to donate blood

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Donation

Duration - Single day

Participants donate whole blood or undergo plasma/platelet apheresis donation depending on their assigned group.

1 donation visit (in-person)

Sample Monitoring

Duration - Up to 42 days

Blood products collected from donations are monitored over time to assess platelet-related inflammatory potential throughout storage.

Multiple sample assessments on Days 2, 4, 6, 8, 10, 12, 14, 21, 28, 35, and 42

Trial Site Locations

Total: 1 location

1

Maison du don de l'EFS Auvergne Rhônes-Alpes

Saint-Etienne, France, 42100

Actively Recruiting

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Research Team

H

Hind HAMZEH-COGNASSE, PhD, HDR

F

Fabrice COGNASSE, PhD, HDR

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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