Back to resultsPlasmapheresis: a Multi-modal Approach
Primary Purpose
Plasmapheresis, Haematology, Sport Performance
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Plasmapheresis
Sponsored by
About this trial
This is an interventional health services research trial for Plasmapheresis
Eligibility Criteria
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.
Sites / Locations
- UCLouvain
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Low-frequency
High-frequency
US scheme
Arm Description
Simulated plasma donation, same procedure as for plasmapheresis but without drawing blood.
Plasma donation 1x/month for 3 months
Plasma donation 3x/month for 3 months
Plasma donation 2x/week for 3 months
Outcomes
Primary Outcome Measures
Blood markers
albumin in g/l
Blood markers
Immunoglobulins G, M and A in G/l
Sport performance
VO2max in mlO2/kg/min determined breath-by-breath on a cycloergometer
Sport performance
maximal force of the quadriceps in kg measured on a leg extension machine
Secondary Outcome Measures
Body composition
fat mass in kg measured by DEXA
Body composition
lean mass in kg measured by DEXA
Blood pressure
systolic and diastolic blood pressure in mmHG
Full Information
NCT ID
NCT05815615
First Posted
March 20, 2023
Last Updated
April 3, 2023
Sponsor
Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT05815615
Brief Title
Plasmapheresis: a Multi-modal Approach
Official Title
Study of the Side Effects of Plasmapheresis: a Multi-modal Approach
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasmapheresis, Haematology, Sport Performance, Body Composition, Inflammation, Immunology, Adverse Events
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Simulated plasma donation, same procedure as for plasmapheresis but without drawing blood.
Arm Title
Low-frequency
Arm Type
Experimental
Arm Description
Plasma donation 1x/month for 3 months
Arm Title
High-frequency
Arm Type
Experimental
Arm Description
Plasma donation 3x/month for 3 months
Arm Title
US scheme
Arm Type
Experimental
Arm Description
Plasma donation 2x/week for 3 months
Intervention Type
Device
Intervention Name(s)
Plasmapheresis
Intervention Description
Plasma donation at different frequencies
Primary Outcome Measure Information:
Title
Blood markers
Description
albumin in g/l
Time Frame
3 months
Title
Blood markers
Description
Immunoglobulins G, M and A in G/l
Time Frame
3 months
Title
Sport performance
Description
VO2max in mlO2/kg/min determined breath-by-breath on a cycloergometer
Time Frame
3 months
Title
Sport performance
Description
maximal force of the quadriceps in kg measured on a leg extension machine
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Body composition
Description
fat mass in kg measured by DEXA
Time Frame
3 months
Title
Body composition
Description
lean mass in kg measured by DEXA
Time Frame
3 months
Title
Blood pressure
Description
systolic and diastolic blood pressure in mmHG
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Blood markers
Description
red blood cells in 10^6/mm^3
Time Frame
3 months
Title
Blood markers
Description
haemoglobin in g/dl
Time Frame
3 months
Title
Blood markers
Description
haematocrit in %
Time Frame
3 months
Title
Blood markers
Description
iron in ug/dl
Time Frame
3 months
Title
Blood markers
Description
ferritin in ug/l
Time Frame
3 months
Title
Blood markers
Description
glycated haemoglobin in %
Time Frame
3 months
Title
Blood markers
Description
creatine kinase in U/l
Time Frame
3 months
Title
Blood markers
Description
total cholesterol in mg/dl
Time Frame
3 months
Title
Blood markers
Description
reticulocytes in %
Time Frame
3 months
Title
Weight
Description
in kg
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
UCLouvain
City
Louvain-la-Neuve
State/Province
Brabant Wallon
ZIP/Postal Code
1348
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Plasmapheresis: a Multi-modal Approach
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