Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT06530160
Brief Summary:
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.
Detailed Description:
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).
Study:
NCT06530160
Study Brief:
Protocol Section:
NCT06530160