Plasmapheresis: a Multi-modal Approach

Study Overview
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Brief Summary
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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.

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

Conditions
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Plasmapheresis, Haematology, Sport Performance, Body Composition, Inflammation, Immunology, Adverse Events

Intervention / Treatment
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* Device: Plasmapheresis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Simulated plasma donation, same procedure as for plasmapheresis but without drawing blood. | Device: Plasmapheresis<br>* Plasma donation at different frequencies<br>|
| Experimental: Low-frequency<br>Plasma donation 1x/month for 3 months | Device: Plasmapheresis<br>* Plasma donation at different frequencies<br>|
| Experimental: High-frequency<br>Plasma donation 3x/month for 3 months | Device: Plasmapheresis<br>* Plasma donation at different frequencies<br>|
| Experimental: US scheme<br>Plasma donation 2x/week for 3 months | Device: Plasmapheresis<br>* Plasma donation at different frequencies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood markers | albumin in g/l | 3 months | 
| Blood markers | Immunoglobulins G, M and A in G/l | 3 months | 
| Sport performance | VO2max in mlO2/kg/min determined breath-by-breath on a cycloergometer | 3 months | 
| Sport performance | maximal force of the quadriceps in kg measured on a leg extension machine | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | fat mass in kg measured by DEXA | 3 months | 
| Body composition | lean mass in kg measured by DEXA | 3 months | 
| Blood pressure | systolic and diastolic blood pressure in mmHG | 3 months |