Plasmapheresis: a Multi-modal Approach

Université Catholique de Louvain

Status: Completed

Conditions: Haematology; Plasmapheresis; Immunology; Inflammation; Adverse Events; Sport Performance; Body Composition

Treatments: Device: Plasmapheresis

Study type: Interventional

Funder types: Other

Identifiers

NCT05815615

RK2020

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

• 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 design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Device: Plasmapheresis

Low-frequency

Experimental group

Description:

Plasma donation 1x/month for 3 months

Treatment:

Device: Plasmapheresis

High-frequency

Experimental group

Description:

Plasma donation 3x/month for 3 months

Treatment:

Device: Plasmapheresis

US scheme

Experimental group

Description:

Plasma donation 2x/week for 3 months

Treatment:

Device: Plasmapheresis