PlasmapheresisNCT05815615
Plasmapheresis: a Multi-modal Approach
A study testing Plasmapheresis in people with Plasmapheresis and Haematology, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Only very few studies have prospectively looked at the effect of repeated intensive plasma donation. In collaboration with the Rode Kruis Vlaanderen, we have recently found that repeated whole blood donation with a 3-month interval in between induced a drop in markers for iron status, which worsened with the number of… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Plasmapheresis, Haematology, Sport Performance
- What is being tested?
- Plasmapheresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2022to 31 Dec 2022
- Phase
- Interventional
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male,
- age between 18-50 years
- BMI between 20-28 kg/m2
- aptitude to perform maximal physical efforts assessed by the physical activity readiness questionnaire (PAR-Q)
Who cannot join
- The specific exclusion criteria of the Rode Kruis Vlaanderen for blood donation will not be systematically applied to the present study to increase the pool of recruitment.
- In case the subjects do not comply with the criteria of the Rode Kruis Vlaanderen, their plasma donations will be thrown away.
- In case the subjects comply, their plasma donations will be handled as usually.
- The criteria will be assessed before each plasma donation by a questionnaire as usually done in the Center of the Rode Kruis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Side Effects of Plasmapheresis: a Multi-modal Approach
Only very few studies have prospectively looked at the effect of repeated intensive plasma donation. In collaboration with the Rode Kruis Vlaanderen, we have recently found that repeated whole blood donation with a 3-month interval in between induced a drop in markers for iron status, which worsened with the number of donations. The repetition effect of the donations, whether whole blood or plasma, can be different from the effects measured after one single donation. It is therefore critical to test and document this repetitive effect to build trustable and valid guidelines concerning repetitive plasma donation.
- Conditions
- Plasmapheresis, Haematology, Sport Performance, Body Composition, Inflammation, Immunology
- Being tested
- Plasmapheresis
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmapheresisDevice
Plasma donation at different frequencies
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Simulated plasma donation, same procedure as for plasmapheresis but without drawing blood. Receives: Device: Plasmapheresis |
| Low-frequency | Experimental | Plasma donation 1x/month for 3 months Receives: Device: Plasmapheresis |
| High-frequency | Experimental | Plasma donation 3x/month for 3 months Receives: Device: Plasmapheresis |
| US scheme | Experimental | Plasma donation 2x/week for 3 months Receives: Device: Plasmapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood markers
albumin in g/l
Measured: 3 months
Blood markers
Immunoglobulins G, M and A in G/l
Measured: 3 months
Sport performance
VO2max in mlO2/kg/min determined breath-by-breath on a cycloergometer
Measured: 3 months
Sport performance
maximal force of the quadriceps in kg measured on a leg extension machine
Measured: 3 months
Secondary outcomes (3)
Body composition
fat mass in kg measured by DEXA
Measured: 3 months
Body composition
lean mass in kg measured by DEXA
Measured: 3 months
Blood pressure
systolic and diastolic blood pressure in mmHG
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Mar 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PlasmapheresisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815615
- Sponsor's protocol ID
- RK2020
- Status last verified
- Apr 2023
- First submitted
- 20 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Side Effects of Plasmapheresis: a Multi-modal Approach
- ClinicalTrials.gov ID
- NCT05815615
- Acronym / sponsor ID
- RK2020
- Conditions
- Plasmapheresis, Haematology, Sport Performance, Body Composition, Inflammation, Immunology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 Apr 2023 (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.
Only very few studies have prospectively looked at the effect of repeated intensive plasma donation. In collaboration with the Rode Kruis Vlaanderen, we have recently found that repeated whole blood donation with a 3-month interval in between induced a drop in markers for iron status, which worsened with the number of donations. The repetition effect of the donations, whether whole blood or plasma, can be different from the effects measured after one single donation. It is therefore critical to test and document this repetitive effect to build trustable and valid guidelines concerning repetitive plasma donation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Device: PlasmapheresisSimulated plasma donation, same procedure as for plasmapheresis but without drawing blood. |
| Low-frequency | Experimental | Device: PlasmapheresisPlasma donation 1x/month for 3 months |
| High-frequency | Experimental | Device: PlasmapheresisPlasma donation 3x/month for 3 months |
| US scheme | Experimental | Device: PlasmapheresisPlasma donation 2x/week for 3 months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- male,
- age between 18-50 years
- BMI between 20-28 kg/m2
- aptitude to perform maximal physical efforts assessed by the physical activity readiness questionnaire (PAR-Q)
Key exclusion criteria (4 listed)
- The specific exclusion criteria of the Rode Kruis Vlaanderen for blood donation will not be systematically applied to the present study to increase the pool of recruitment.
- The criteria will be assessed before each plasma donation by a questionnaire as usually done in the Center of the Rode Kruis.
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 |
|---|---|---|
| PlasmapheresisPlasma donation at different frequencies | Device | High-frequency, Low-frequency, Placebo, US scheme |
Primary outcome
Blood markers
Time frame: 3 months
albumin in g/l
Blood markers
Time frame: 3 months
Immunoglobulins G, M and A in G/l
Sport performance
Time frame: 3 months
VO2max in mlO2/kg/min determined breath-by-breath on a cycloergometer
Sport performance
Time frame: 3 months
maximal force of the quadriceps in kg measured on a leg extension machine
3 secondary outcomes
Body composition
Time frame: 3 months
Body composition
Time frame: 3 months
Blood pressure
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasmapheresis in people with Plasmapheresis and Haematology, run by Université Catholique de Louvain at 1 site in Belgium.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 18 Apr 2023. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood markers (time frame: 3 months). The study lists 4 primary outcomes in all. 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 18 Apr 2023.