Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-03 @ 9:52 AM
Study NCT ID:
NCT06530160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-31
First Post:
2024-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interleukin-8 Level in Packed Red Blood Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004797', 'term': 'Enzyme-Linked Immunosorbent Assay'}], 'ancestors': [{'id': 'D007124', 'term': 'Immunoenzyme Techniques'}, {'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007163', 'term': 'Immunosorbent Techniques'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2029-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-27', 'studyFirstSubmitDate': '2024-07-27', 'studyFirstSubmitQcDate': '2024-07-27', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare level of interleukin-8 between leukodepleted and non-leukodepleted packed red blood cells', 'timeFrame': 'Baseline', 'description': 'Show the effect of filteration of packed red blood cells on the level of inflammatory interleukin-8'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interleukin-8'], 'conditions': ['Packed Red Blood Cells']}, 'referencesModule': {'references': [{'pmid': '29087650', 'type': 'BACKGROUND', 'citation': 'Anaya JM, Shoenfeld Y, Rojas-Villarraga A, Levy RA, Cervera R, editors. Autoimmunity: From Bench to Bedside [Internet]. Bogota (Colombia): El Rosario University Press; 2013 Jul 18. Available from http://www.ncbi.nlm.nih.gov/books/NBK459447/'}, {'pmid': '24892271', 'type': 'BACKGROUND', 'citation': 'Turner MD, Nedjai B, Hurst T, Pennington DJ. Cytokines and chemokines: At the crossroads of cell signalling and inflammatory disease. Biochim Biophys Acta. 2014 Nov;1843(11):2563-2582. doi: 10.1016/j.bbamcr.2014.05.014. Epub 2014 Jun 2.'}, {'pmid': '1918386', 'type': 'BACKGROUND', 'citation': 'Darbonne WC, Rice GC, Mohler MA, Apple T, Hebert CA, Valente AJ, Baker JB. Red blood cells are a sink for interleukin 8, a leukocyte chemotaxin. J Clin Invest. 1991 Oct;88(4):1362-9. doi: 10.1172/JCI115442.'}, {'pmid': '1702325', 'type': 'BACKGROUND', 'citation': 'Davenport RD, Strieter RM, Standiford TJ, Kunkel SL. Interleukin-8 production in red blood cell incompatibility. Blood. 1990 Dec 15;76(12):2439-42.'}, {'pmid': '26420933', 'type': 'BACKGROUND', 'citation': 'Shukla R, Patel T, Gupte S. Release of cytokines in stored whole blood and red cell concentrate: Effect of leukoreduction. Asian J Transfus Sci. 2015 Jul-Dec;9(2):145-9. doi: 10.4103/0973-6247.162708.'}]}, 'descriptionModule': {'briefSummary': '1. To compare level of interleukin-8 between leukodepleted and non-leukodepleted packed red blood cells.\n2. To show the effect of filtration of packed red blood cells on the level of inflammatory interleukin-8.', 'detailedDescription': '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.\n\nThe cytokines are small cell-signaling protein molecules with several functions,e.g.: Intracrine, Autocrine and Intercrine actions (1).\n\nThey 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).\n\nCytokines 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).\n\nInterleukin-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).\n\nInterleukin-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).\n\nLeukoreduction (LR) is a potential means of preventing cytokine production (6).\n\nThus 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy donors', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Donors not fulfilling all general criteria for blood donation according to World Health Organization:\n* Age between 18 and 65\n* Weight at least 50 kg\n* Haemoglobin not less than 13 g/dl in males and 12 g/dl in females\n* must be in good health at the time of donation\n* Cannot donate if have a cold, flu, sore throat, cold sore, stomach bug or any other infection.\n* Have ever had a positive test for HIV (AIDS virus)\n* It is not advisable to donate blood while Breast-feeding'}, 'identificationModule': {'nctId': 'NCT06530160', 'briefTitle': 'Interleukin-8 Level in Packed Red Blood Cells', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparison Between Leukodepleted and Non-Leukodepleted Packed Red Blood Cells in Interleukin-8 Level as an Inflammatory Cytokine', 'orgStudyIdInfo': {'id': 'Interleukin-8 in packed Rbcs'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ELISA', 'type': 'OTHER', 'description': 'Enzyme-linked immunosorbent assay'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wesam Ashraf Soliman', 'role': 'CONTACT', 'email': 'wesamashraf27@gmail.com', 'phone': '01095574120'}, {'name': 'Rania Mohamed Bakry', 'role': 'CONTACT', 'email': 'Rbakry.md@aun.edu.eg', 'phone': '01013341395'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Wesam Ashraf Soliman Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}