NCT06530160

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
43mo left

Started Jan 2025

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Jan 2025Oct 2029

First Submitted

Initial submission to the registry

July 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2029

Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

3.3 years

First QC Date

July 27, 2024

Last Update Submit

July 27, 2024

Conditions

Keywords

Interleukin-8

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Interventions

ELISAOTHER

Enzyme-linked immunosorbent assay

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy donors

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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: 29087650BACKGROUND
  • 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: 24892271BACKGROUND
  • 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: 1918386BACKGROUND
  • 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: 1702325BACKGROUND
  • 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.

    PMID: 26420933BACKGROUND

MeSH Terms

Interventions

Enzyme-Linked Immunosorbent Assay

Intervention Hierarchy (Ancestors)

Immunoenzyme TechniquesImmunoassayImmunologic TechniquesInvestigative TechniquesImmunosorbent TechniquesImmunohistochemistryMolecular Probe Techniques

Central Study Contacts

Wesam Ashraf Soliman

CONTACT

Rania Mohamed Bakry

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

July 27, 2024

First Posted

July 31, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

October 30, 2029

Last Updated

July 31, 2024

Record last verified: 2024-07