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Healthy DonorsNCT07821736

Impact of Leukoreduction Timing on Plasma Citrullinated Histone H3 (H3cit) Dynamics and Red Blood Cell Storage Lesions

A study testing H3Cit in people with Healthy Donors, run by Assiut University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

Impact of Leukoreduction Timing on Plasma Citrullinated Histone H3 (H3cit) Dynamics and Red Blood Cell Storage Lesions To measure H3cit levels immediately after filtration on Days 0, 1, 3, and 5. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Donors
What is being tested?
H3Cit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Nov 2026to 1 Dec 2028
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • • Standard whole blood units collected from healthy voluntary donors who meet the national blood transfusion service fitness criteria (age 18-60 years, body weight ≥50 kg).
  • Collection Volume \& Container: Standard unit volume (450 ± 45 mL) collected into closed bag systems with additive/anticoagulant solution (CPDA-1).
  • Thermal Storage Chain: Blood units maintained continuously within standard blood bank temperature limits (2 C to 6C )from collection until the end of the storage period.
  • Baseline Hematological Parameters: Normal baseline hematological profile immediately post-collection (Hemoglobin ≥12.5g dl)

Who cannot join

  • Donor Clinical Factors: Donors with a history of acute or chronic inflammatory conditions, active infections, autoimmune diseases, or those who ingested anti-inflammatory/antiplatelet medications (e.g., NSAIDs, aspirin) within 14 days prior to donation.
  • Technical Collection Complications: Phlebotomy draw time exceeding 12 minutes, difficult venipuncture, or units displaying macro-clots or excessive lipemia post-collection.
  • Storage Excursions \& Bag Damage: Any blood unit subjected to cold-chain temperature violations outside 2-6C, physical damage, or system breaches/leaks.
  • Transfusion-Transmitted Infections (TTI): Units testing reactive for screening markers, including HBsAg, Anti-HCV, Anti-HIV-1/2, or Syphilis
  • Donor Clinical Factors: Donors with a history of acute or chronic inflammatory conditions, active infections, autoimmune diseases, or those who ingested anti-inflammatory/antiplatelet medications (e.g., NSAIDs, aspirin) within 14 days prior to donation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mayar Medhat Thabet, MBBCH contact

+201028494332

mayarmedhatzz22@gmail.com

Egypt1 site
  • Mayar Medhat

    Asyut

    Thabet, +201028494332

Other trials in Egypt

About this study

Impact of Leukoreduction Timing on Plasma Citrullinated Histone H3 (H3cit) Dynamics and Red Blood Cell Storage Lesions To measure H3cit levels immediately after filtration on Days 0, 1, 3, and 5. To measure H3cit levels during storage at mid-storage and shelf-life end To correlate H3cit levels with standard blood storage markers

Read the detailed description

Packed red blood cells (PRBCs) are the most commonly transfused blood component and play a critical role in treating anemia, trauma, and surgical patients. However, during refrigerated storage, PRBCs undergo a sequence of biochemical, metabolic, and structural changes collectively referred to as the "storage lesion." These changes include depletion of adenosine triphosphate (ATP) and 2,3-diphosphoglycerate (2,3-DPG), glucose utilization, lactate production, pH changes, potassium loss, oxidative stress, increased free hemoglobin release, and morphological alterations such as decreased deformability and microparticle formation. Such changes can impair erythrocyte function and survival following transfusion, particularly in critically ill patients and those requiring massive transfusion Studies have demonstrated that markers of NETs increase during RBC storage and are significantly higher in non-leukoreduced units compared to leukoreduced units(5) Specifically, in canine models, day 42 non-leukoreduced units contained approximately 1000-fold more cell-free DNA than leukoreduced units, with significantly higher Cit-H3 levels Leukoreduction, the removal of white blood cells from blood products, is performed to reduce transfusion reactions and immunomodulation. Pre-storage leukoreduction has been shown to prevent cytokine accumulation during storage and reduce the risk of febrile nonhemolytic transfusion reactions and TRALI The timing of leukoreduction is critical, as pre-storage filtration prevents the accumulation of leukocyte-derived bioactive substances that occur during storage, whereas post-storage filtration does not Importantly, universal leukoreduction has been associated with an 83% decrease in TRALI rates, highlighting the clinical significance of leukocyte removal Neutrophil extracellular traps (NETs) are web-like structures composed of DNA, histones, and neutrophil granular proteins extruded from activated neutrophils. NETs have been implicated in cytotoxicity, thrombosis, and autoimmunity, and they play a role in the pathogenesis of transfusion-related acute lung injury (TRALI) Citrullinated histone H3 (Cit-H3) is a specific marker of NETosis, as NET formation requires histone citrullination by peptidylarginine deiminase 4 (PAD4) Given the established role of NETs in transfusion-related complications and the potential for Cit-H3 to serve as a quality marker, this study aims to evaluate Cit-H3 levels in stored RBC units and assess its correlation with storage duration and leukoreduction timing. The findings could provide insights into optimizing storage conditions and improving transfusion outcomes through better identification and mitigation of storage lesions

Conditions
Healthy Donors
Being tested
H3Cit
Keywords
Leukoreduction timing on H3Cit

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • H3CitOther

    To measure H3cit levels during storage at mid-storage and shelf-life end

Study groups in NCT07821736
Study groupRoleWhat they receive
Leukoreduction Timing on H3CitExperimentalNot described
Receives: Other: H3Cit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To measure H3cit levels immediately after filtration

    Measured: on Days 0, 1, 3, and 5.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 May 2028 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07821736
Sponsor's protocol ID
Leukoreduction Timing on H3cit
Status last verified
Sep 2026
First submitted
10 Sep 2026
Last updated
16 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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