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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Simulated plasma donation, same procedure as for plasmapheresis but without drawing blood. |
|
| Low-frequency | Experimental | Plasma donation 1x/month for 3 months |
|
| High-frequency | Experimental | Plasma donation 3x/month for 3 months |
|
| US scheme | Experimental | Plasma donation 2x/week for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasmapheresis | Device | Plasma donation at different frequencies |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood markers | red blood cells in 10^6/mm^3 | 3 months |
| Blood markers | haemoglobin in g/dl | 3 months |
Inclusion criteria:
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.
The criteria will be assessed before each plasma donation by a questionnaire as usually done in the Center of the Rode Kruis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLouvain | Louvain-la-Neuve | Brabant Wallon | 1348 | Belgium |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010956 | Plasmapheresis |
| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
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| Blood pressure | systolic and diastolic blood pressure in mmHG | 3 months |
| Blood markers | haematocrit in % | 3 months |
| Blood markers | iron in ug/dl | 3 months |
| Blood markers | ferritin in ug/l | 3 months |
| Blood markers | glycated haemoglobin in % | 3 months |
| Blood markers | creatine kinase in U/l | 3 months |
| Blood markers | total cholesterol in mg/dl | 3 months |
| Blood markers | reticulocytes in % | 3 months |
| Weight | in kg | 3 months |
| D013514 | Surgical Procedures, Operative |