Plasmapheresis: a Multi-modal Approach

NCT ID: NCT05815615

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-12-31

Brief 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 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; Adverse Events

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Placebo

Simulated plasma donation, same procedure as for plasmapheresis but without drawing blood.

Group Type: PLACEBO_COMPARATOR

Plasmapheresis

Intervention Type: DEVICE

Plasma donation at different frequencies

Low-frequency

Plasma donation 1x/month for 3 months

Group Type: EXPERIMENTAL

Plasmapheresis

Intervention Type: DEVICE

Plasma donation at different frequencies

High-frequency

Plasma donation 3x/month for 3 months

Group Type: EXPERIMENTAL

Plasmapheresis

Intervention Type: DEVICE

Plasma donation at different frequencies

US scheme

Plasma donation 2x/week for 3 months

Group Type: EXPERIMENTAL

Plasmapheresis

Intervention Type: DEVICE

Plasma donation at different frequencies

Interventions

Plasmapheresis

Plasma donation at different frequencies

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UCLouvain

Louvain-la-Neuve, Brabant Wallon, Belgium

Countries

Belgium

Other Identifiers

RK2020

Identifier Type: -

Identifier Source: org_study_id