Plasmapheresis: a Multi-modal Approach

Not Applicable

Completed

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

• Registration Number: NCT05815615
• Lead Sponsor: Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Study First Submitted: 2023-03-20
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-03
• Last Update Submitted: 2023-04-03
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-frequency	Plasmapheresis	Plasma donation 3x/month for 3 months
Placebo	Plasmapheresis	Simulated plasma donation, same procedure as for plasmapheresis but without drawing blood.
Low-frequency	Plasmapheresis	Plasma donation 1x/month for 3 months
US scheme	Plasmapheresis	Plasma donation 2x/week for 3 months

Primary Outcome Measures

Name	Time	Method
Sport performance	3 months	maximal force of the quadriceps in kg measured on a leg extension machine
Blood markers	3 months	Immunoglobulins G, M and A in G/l

Secondary Outcome Measures

Name	Time	Method
Body composition	3 months	lean mass in kg measured by DEXA
Blood pressure	3 months	systolic and diastolic blood pressure in mmHG

Trial Locations

Locations (1)

UCLouvain; 🇧🇪 Louvain-la-Neuve, Brabant Wallon, Belgium