Viewing Study NCT06530160



Ignite Creation Date: 2024-10-25 @ 7:52 PM
Last Modification Date: 2024-10-26 @ 3:36 PM
Study NCT ID: NCT06530160
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-07-27

Brief Title: Interleukin-8 Level in Packed Red Blood Cells
Sponsor: None
Organization: None

Study Overview

Official Title: Comparison Between Leukodepleted and Non-Leukodepleted Packed Red Blood Cells in Interleukin-8 Level as an Inflammatory Cytokine
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 survivaldeath 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 functionseg 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 ie 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 expressed5 IL-8 is produced by monocytes in response to lipopolysaccharide LPS tumor necrosis factor-α TNF-α and IL-16 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None