Packed Red Cells Causing Adverse Effects in Therapeutic UseNCT06428747
Investigating Microparticle Levels In Filtered Packed Red Blood Cell Units
An observational study of Packed Red Cells Causing Adverse Effects in Therapeutic Use, run by Assiut University at 1 site in Egypt.
Trial summary
Red blood cell (RBC) transfusion is a common therapeutic approach, and almost 85 million packed red blood cells (pRBCs) are transfused annually worldwide.Transfusion efficacy largely depends on the patient's general health, but the composition of transfused pRBCs also can have an impact. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Packed Red Cells Causing Adverse Effects in Therapeutic Use
- What is being tested?
- b. Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer).
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 30 Apr 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Group 1: 30 filtered backed RBCs. Group 2: 30 non-filtered backed RBCs.
Who may be able to join
- Donors who met criteria of Egyptian National Transfusion Services.
- Serological assays for all blood donors (HBsAgs, HCV antibodies, HIV Ag/Ab and Syphilis antibodies) on Architect i 2000 SR or Centaur XPT (chemoluminescence).
Who cannot join
- Donors who not met criteria of Egyptian National Transfusion Services.
- Reactive serology.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university
Asyut, 71511
khaled Amir, phD, 01141110942 ext. 02, khaledalamir@yahoo.com
About this study
Red blood cell (RBC) transfusion is a common therapeutic approach, and almost 85 million packed red blood cells (pRBCs) are transfused annually worldwide.Transfusion efficacy largely depends on the patient's general health, but the composition of transfused pRBCs also can have an impact.
Read the detailed description
Red blood cell (RBC) transfusion is a common therapeutic approach, and almost 85 million packed red blood cells (pRBCs) are transfused annually worldwide.Transfusion efficacy largely depends on the patient's general health, but the composition of transfused pRBCs also can have an impact. pRBCs are prepared from donated whole blood and can be stored for up to 35 days.During storage, modifications of RBCs occur and affect product quality. Among other changes, these "storage lesions" induce microparticle (MP) formation. MPs are membrane particles measuring 0.1 to 1 µm produced by stimulated or apoptotic cells through modulation of membrane lipid organization and cytoskeleton reorganization. MPs can be produced from any cell type and express antigens characteristic of their original cell. Blood contains platelet-derived MPs (PMPs), which are the most frequent; RBC (erythrocyte)-derived MPs (ERMPs), representing 4% to 8% of total blood MPs; and, more rarely, MPs produced by endothelial cells and leukocyctes. In vivo, aging RBCs release ERMPs over their whole life cycle as a preventive effect of phagocytosis by macrophages. It seems that MPs quickly spread through the body, leading to a variety of biological effects by contact and interactions with many cells. MPs are well-known bioeffectors that mediate strong procoagulant potential, mainly because of phosphatidylserine and tissue factor expression. In this way, MPs are involved in coagulation disorders associated with atherothrombosis and cardiovascular diseases.Their ability to modulate inflammatory and immune responses is increasingly being studied as well as their capacity to carry and transport RNA, DNA, major histocompatibility complex molecules, and infectious agents. Moreover, depending on the type of stimulation that induces MP production, the size and biological functions of the MP can vary.
- Being tested
- b. Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
b. Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer).Diagnostic test
detection of micro-particles
| Study group | Role | What they receive |
|---|---|---|
| 30 filtered backed RBCs. | detection of micro-particles. Receives: Diagnostic Test: b. Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer). | |
| 30 non-filtered backed RBCs. | detection of micro-particles Receives: Diagnostic Test: b. Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer). - CD235 for red blood cell micro particles. - CD 45 for leukocyte micro particles. - CD41 for platelet micro particles. formation.
Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer).
- CD235 for red blood cell micro particles.
- CD 45 for leukocyte micro particles.
- CD41 for platelet micro particles.
Measured: 7 days
Secondary outcomes (1)
d. Quantification of micro particles in non filtered packed RBCs (pRBCs) versus filtered (pRBCs) over storage period at 4°C.
Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer).
- CD235 for red blood cell micro particles.
- CD 45 for leukocyte micro particles.
- CD41 for platelet micro particles.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Apr 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Packed Red Cells Causing Adverse Effects in Therapeutic UseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doha Fahmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428747
- Sponsor's protocol ID
- Doha Sholkamy
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Microparticle Levels In Filtered Packed Red Blood Cell Units
- ClinicalTrials.gov ID
- NCT06428747
- Acronym / sponsor ID
- Doha Sholkamy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 24 May 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.
Red blood cell (RBC) transfusion is a common therapeutic approach, and almost 85 million packed red blood cells (pRBCs) are transfused annually worldwide.Transfusion efficacy largely depends on the patient's general health, but the composition of transfused pRBCs also can have an impact.
Detailed description
Red blood cell (RBC) transfusion is a common therapeutic approach, and almost 85 million packed red blood cells (pRBCs) are transfused annually worldwide.Transfusion efficacy largely depends on the patient's general health, but the composition of transfused pRBCs also can have an impact. pRBCs are prepared from donated whole blood and can be stored for up to 35 days.During storage, modifications of RBCs occur and affect product quality. Among other changes, these "storage lesions" induce microparticle (MP) formation. MPs are membrane particles measuring 0.1 to 1 µm produced by stimulated or apoptotic cells through modulation of membrane lipid organization and cytoskeleton reorganization. MPs can be produced from any cell type and express antigens characteristic of their original cell. Blood contains platelet-derived MPs (PMPs), which are the most frequent; RBC (erythrocyte)-derived MPs (ERMPs), representing 4% to 8% of total blood MPs; and, more rarely, MPs produced by endothelial cells and leukocyctes. In vivo, aging RBCs release ERMPs over their whole life cycle as a preventive effect of phagocytosis by macrophages. It seems that MPs quickly spread through the body, leading to a variety of biological effects by contact and interactions with many cells. MPs are well-known bioeffectors that mediate strong procoagulant potential, mainly because of phosphatidylserine and tissue factor expression. In this way, MPs are involved in coagulation disorders associated with atherothrombosis and cardiovascular diseases.Their ability to modulate inflammatory and immune responses is increasingly being studied as well as their capacity to carry and transport RNA, DNA, major histocompatibility complex molecules, and infectious agents. Moreover, depending on the type of stimulation that induces MP production, the size and biological functions of the MP can vary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 filtered backed RBCs. | – | Diagnostic Test: b. Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer).detection of micro-particles. |
| 30 non-filtered backed RBCs. | – | Diagnostic Test: b. Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer).detection of micro-particles |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Group 1: 30 filtered backed RBCs. Group 2: 30 non-filtered backed RBCs.
Key inclusion criteria (2 listed)
- Donors who met criteria of Egyptian National Transfusion Services.
- Serological assays for all blood donors (HBsAgs, HCV antibodies, HIV Ag/Ab and Syphilis antibodies) on Architect i 2000 SR or Centaur XPT (chemoluminescence).
Key exclusion criteria (2 listed)
- Donors who not met criteria of Egyptian National Transfusion Services.
- Reactive serology.
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 |
|---|---|---|
| b. Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer).detection of micro-particles | Diagnostic test | 30 filtered backed RBCs., 30 non-filtered backed RBCs. |
Primary outcome
Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer). - CD235 for red blood cell micro particles. - CD 45 for leukocyte micro particles. - CD41 for platelet micro particles. formation.
Time frame: 7 days
Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer). * CD235 for red blood cell micro particles. * CD 45 for leukocyte micro particles. * CD41 for platelet micro particles.
1 secondary outcome
d. Quantification of micro particles in non filtered packed RBCs (pRBCs) versus filtered (pRBCs) over storage period at 4°C.
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Packed Red Cells Causing Adverse Effects in Therapeutic Use, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doha Sholkamy, phD (01097858588 ext. 02, yfahmy330@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer). - CD235 for red blood cell micro particles. - CD 45 for leukocyte micro particles. - CD41 for platelet micro particles. formation. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2024.