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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05815615
Other study ID # RK2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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