Packed Red Blood CellsNCT06530160
Interleukin-8 Level in Packed Red Blood Cells
An observational study of Packed Red Blood Cells, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Packed Red Blood Cells
- What is being tested?
- ELISA
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy donors
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Between Leukodepleted and Non-Leukodepleted Packed Red Blood Cells in Interleukin-8 Level as an Inflammatory Cytokine
- To compare level of interleukin-8 between leukodepleted and non-leukodepleted packed red blood cells.
- To show the effect of filtration of packed red blood cells on the level of inflammatory interleukin-8.
Read the 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).
- Conditions
- Packed Red Blood Cells
- Being tested
- ELISA
- Keywords
- Interleukin-8
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISAOther
Enzyme-linked immunosorbent assay
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare level of interleukin-8 between leukodepleted and non-leukodepleted packed red blood cells
Show the effect of filteration of packed red blood cells on the level of inflammatory interleukin-8
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Packed Red Blood CellsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wesam Ashraf Soliman Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530160
- Sponsor's protocol ID
- Interleukin-8 in packed Rbcs
- Status last verified
- Jul 2024
- First submitted
- 27 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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/
PubMed 29087650Turner 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.
PubMed 24892271Darbonne 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.
PubMed 1918386Davenport RD, Strieter RM, Standiford TJ, Kunkel SL. Interleukin-8 production in red blood cell incompatibility. Blood. 1990 Dec 15;76(12):2439-42.
PubMed 1702325Shukla 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.
PubMed 26420933
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Leukodepleted and Non-Leukodepleted Packed Red Blood Cells in Interleukin-8 Level as an Inflammatory Cytokine
- ClinicalTrials.gov ID
- NCT06530160
- Acronym / sponsor ID
- Interleukin-8 in packed Rbcs
- Conditions
- Packed Red Blood Cells
- Keywords
- Interleukin-8
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To compare level of interleukin-8 between leukodepleted and non-leukodepleted packed red blood cells.
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy donors
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISAEnzyme-linked immunosorbent assay | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Background: PubMed 29087650Anaya 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/
- Background: PubMed 24892271Turner 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.
- Background: PubMed 1918386Darbonne 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.
- Background: PubMed 1702325Davenport RD, Strieter RM, Standiford TJ, Kunkel SL. Interleukin-8 production in red blood cell incompatibility. Blood. 1990 Dec 15;76(12):2439-42.
- Background: PubMed 26420933Shukla 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Packed Red Blood Cells, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wesam Ashraf Soliman (01095574120, wesamashraf27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare level of interleukin-8 between leukodepleted and non-leukodepleted packed red blood cells (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06530160, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.