Plasmapheresis: a Multi-modal Approach

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05815615
• Other study ID #: RK2020
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Events
• Body Composition
• Haematology
• Immunology
• Inflammation
• Plasmapheresis
• Sport Performance

Intervention

Device:
• Plasmapheresis
Plasma donation at different frequencies

Locations

Country	Name	City	State
Belgium	UCLouvain	Louvain-la-Neuve	Brabant Wallon

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood markers	red blood cells in 10^6/mm^3	3 months
Other	Blood markers	haemoglobin in g/dl	3 months
Other	Blood markers	haematocrit in %	3 months
Other	Blood markers	iron in ug/dl	3 months
Other	Blood markers	ferritin in ug/l	3 months
Other	Blood markers	glycated haemoglobin in %	3 months
Other	Blood markers	creatine kinase in U/l	3 months
Other	Blood markers	total cholesterol in mg/dl	3 months
Other	Blood markers	reticulocytes in %	3 months
Other	Weight	in kg	3 months
Primary	Blood markers	albumin in g/l	3 months
Primary	Blood markers	Immunoglobulins G, M and A in G/l	3 months
Primary	Sport performance	VO2max in mlO2/kg/min determined breath-by-breath on a cycloergometer	3 months
Primary	Sport performance	maximal force of the quadriceps in kg measured on a leg extension machine	3 months
Secondary	Body composition	fat mass in kg measured by DEXA	3 months
Secondary	Body composition	lean mass in kg measured by DEXA	3 months
Secondary	Blood pressure	systolic and diastolic blood pressure in mmHG	3 months