Group O leukocyte‑free whole blood: storage effects and inflammation
grouP O wholE blooD (LTO-WB): storagE leSion impacT And infLammation
NA · Etablissement Français du Sang · NCT06809010
This project tests whether group O leukocyte‑free whole blood (LTOWB) causes different inflammatory and biological changes than standard separated blood products using donations from healthy adult blood donors.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Etablissement Français du Sang (other) |
| Locations | 1 site (Saint-Etienne) |
| Trial ID | NCT06809010 on ClinicalTrials.gov |
What this trial studies
The study compares inflammatory and laboratory characteristics of LTOWB produced by the military transfusion center with conventional blood products prepared by the national blood service. Researchers will use in vitro and in vivo tools and biomarker panels to compare platelet‑related, red blood cell‑related, and circulating inflammatory molecule differences between LTOWB and pooled or apheresis platelets, RBC concentrates, and fresh frozen plasma. Samples come from consenting healthy donors who meet standard donation criteria and are processed according to each center's procedures. Results aim to define biomarkers that could guide optimal use of LTOWB in operational and civilian settings.
Who should consider this trial
Good fit: Healthy adults who are eligible for blood donation—aged 18–70 for whole blood donation (18–65 for apheresis), weigh at least 50 kg, and meet standard donor health criteria—are ideal candidates.
Not a fit: People who need immediate transfusion, are ineligible to donate, or expect direct medical treatment from participation should not expect personal clinical benefit from joining this project.
Why it matters
Potential benefit: If successful, the work could clarify inflammatory risks of LTOWB and help guide safer use of whole blood in trauma and austere environments.
How similar studies have performed: Previous clinical work supports LTOWB's effectiveness for hemorrhage control, but the product's platelet‑linked inflammatory effects have not been fully studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Saint-Etienne
- Maison du don de l'EFS Auvergne Rhônes-Alpes — Saint-Etienne, France (RECRUITING)
Study contacts
- Study coordinator: Hind HAMZEH-COGNASSE, PhD, HDR
- Email: hind.hamzeh@univ-st-etienne.fr
- Phone: +33 477 421 400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Blood Donation, Blood Platelets, Blood Donors, Inflammation, Transfusion, blood, LTO-WB, characterization of labile blood products