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NCT Number: NCT05815615

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.

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Key information

Conditions

Plasmapheresis Adverse Events Body Composition Haematology Immunology Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sport Performance

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UCLouvain

Louvain-la-Neuve, Brabant Wallon, 1348, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

plasmapheresis

Device

Plasma donation at different frequencies

Primary outcomes

  1. Blood markers

    Time frame: 3 months

    albumin in g/l

  2. Blood markers

    Time frame: 3 months

    Immunoglobulins G, M and A in G/l

  3. Sport performance

    Time frame: 3 months

    VO2max in mlO2/kg/min determined breath-by-breath on a cycloergometer

  4. Sport performance

    Time frame: 3 months

    maximal force of the quadriceps in kg measured on a leg extension machine

Secondary outcomes

  1. Body composition

    Time frame: 3 months

    fat mass in kg measured by DEXA

  2. Body composition

    Time frame: 3 months

    lean mass in kg measured by DEXA

  3. Blood pressure

    Time frame: 3 months

    systolic and diastolic blood pressure in mmHG

Other outcomes

  1. Blood markers

    Time frame: 3 months

    red blood cells in 10^6/mm^3

  2. Blood markers

    Time frame: 3 months

    haemoglobin in g/dl

  3. Blood markers

    Time frame: 3 months

    haematocrit in %

  4. Blood markers

    Time frame: 3 months

    iron in ug/dl

  5. Blood markers

    Time frame: 3 months

    ferritin in ug/l

  6. Blood markers

    Time frame: 3 months

    glycated haemoglobin in %

  7. Blood markers

    Time frame: 3 months

    creatine kinase in U/l

  8. Blood markers

    Time frame: 3 months

    total cholesterol in mg/dl

  9. Blood markers

    Time frame: 3 months

    reticulocytes in %

  10. Weight

    Time frame: 3 months

    in kg

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study title

Study of the Side Effects of Plasmapheresis: a Multi-modal Approach

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2023
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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