Inflammation Clinical Trial
Official title:
Study of the Side Effects of Plasmapheresis: a Multi-modal Approach
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 |
Verified date | April 2023 |
Source | Université Catholique de Louvain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | UCLouvain | Louvain-la-Neuve | Brabant Wallon |
Lead Sponsor | Collaborator |
---|---|
Université Catholique de Louvain |
Belgium,
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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