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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

• 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.

Disqualifiers

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.

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 design

Design model

Single group

Treatments tested in this trial

  • H3Cit

    Other intervention

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

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Leukoreduction Timing on H3CitExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To measure H3cit levels immediately after filtration

Time frame
on Days 0, 1, 3, and 5.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: