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NCT Number: NCT06530160

Interleukin-8 Level in Packed Red Blood Cells

1. To compare level of interleukin-8 between leukodepleted and non-leukodepleted packed red blood cells. 2. To show the effect of filtration of packed red blood cells on the level of inflammatory interleukin-8.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

The term cytokine was proposed by Stanley Cohen in 1974 and refers to peptides, proteins, and glycoproteins which play a role in controlling the survival/death of cells, their growth and differentiation as well as the effector functions in tissues and immune cells.

The cytokines are small cell-signaling protein molecules with several functions,e.g.: Intracrine, Autocrine and Intercrine actions (1).

They are synthesized by different immune cells, mainly by T cells, neutrophils and macrophages, which are responsible to promote and regulate immune response (i.e. activity, differentiation, proliferation and production of cells and other cytokines) (2).

Cytokines are described as being pro-inflammatory or antiinflammatory, both of which accumulate in blood products during storage mainly as a result of damaged leucocytes. The accumulation of pro-inflammatory cytokines, is regarded as one of the major causative factors For Transfusion-Associated Adverse Reactions (TAARs), particularly Febrile Non-Haemolytic Transfusion Reactions (FNHTRs) and Transfusion-Related Immunomodulation (TRIM). In addition, the transfusion of blood products containing cytokines has been associated with transfusion-induced systemic inflammation in patients with pre-activated endothelial cells (3).

Interleukin-8 (also known as neutrophil-activating peptide 1) is recognized as a potent effector of neutrophil functions. Several different cell types that contact blood, namely T lymphocytes, monocytes, and endothelial cells, secrete this polypeptide following stimulation by cytokines, or lipopolysaccharide (4).

Interleukin-8 (IL-8), a cytokine with chemotactic and activating properties for neutrophils, has recently been isolated, cloned, and expressed.5 IL-8 is produced by monocytes in response to lipopolysaccharide (LPS), tumor necrosis factor-α (TNF-α), and IL-1;6 and has been implicated in the pathogenesis of acute lung injury. Therefore, we hypothesized that IL-8 may be a mediator of the pathologic events in hemolytic transfusion reaction (HTR), and designed an in vitro model of red blood cell (RBC) incompatibility to investigate the possible role of IL-8 in this setting (5).

Leukoreduction (LR) is a potential means of preventing cytokine production (6).

Thus reducing the white blood cell (WBC) content (leukodepletion) in cellular blood components to a significant level has a direct impact on reducing the incidence of many adverse effects of transfusion-associated with leukocytes and cytokines present in higher levels in non leukodepleted blood component (7).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • In total, 82 donors fulfilling all general criteria for blood donation, different blood groups and socioeconomic backgrounds, males and females belonging to this geographical area.

Exclusion criteria

  • Donors not fulfilling all general criteria for blood donation according to World Health Organization:
  • Age between 18 and 65
  • Weight at least 50 kg
  • Haemoglobin not less than 13 g/dl in males and 12 g/dl in females
  • must be in good health at the time of donation
  • Cannot donate if have a cold, flu, sore throat, cold sore, stomach bug or any other infection.
  • Have ever had a positive test for HIV (AIDS virus)
  • It is not advisable to donate blood while Breast-feeding

Treatment and study plan

ELISA

Other

Enzyme-linked immunosorbent assay

Primary outcomes

  1. Compare level of interleukin-8 between leukodepleted and non-leukodepleted packed red blood cells

    Time frame: Baseline

    Show the effect of filteration of packed red blood cells on the level of inflammatory interleukin-8

Study contacts

Contact information is provided by the study sponsor or research team.

Rania Mohamed Bakry

CONTACT

[email protected]

01013341395

Wesam Ashraf Soliman

CONTACT

[email protected]

01095574120

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Comparison Between Leukodepleted and Non-Leukodepleted Packed Red Blood Cells in Interleukin-8 Level as an Inflammatory Cytokine

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.