Plasmapheresis: a Multi-modal Approach

• Sponsor: Université Catholique de Louvain (Other)
• Overall Status: Completed
• CT.gov ID: NCT05815615
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 4
• Actual Duration (Months): 10
• Patients Per Site Per Month: 7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Plasmapheresis; Haematology; Sport Performance; Body Composition; Inflammation; Immunology; Adverse Events	Device: Plasmapheresis	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Study of the Side Effects of Plasmapheresis: a Multi-modal Approach
• Actual Study Start Date: Mar 1, 2022
• Actual Primary Completion Date: Dec 31, 2022
• Actual Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Simulated plasma donation, same procedure as for plasmapheresis but without drawing blood.	Device: Plasmapheresis; Plasma donation at different frequencies
Experimental: Low-frequency Plasma donation 1x/month for 3 months	Device: Plasmapheresis; Plasma donation at different frequencies
Experimental: High-frequency Plasma donation 3x/month for 3 months	Device: Plasmapheresis; Plasma donation at different frequencies
Experimental: US scheme Plasma donation 2x/week for 3 months	Device: Plasmapheresis; Plasma donation at different frequencies

Outcome Measures

Primary Outcome Measures

1. Blood markers [3 months]

   albumin in g/l

2. Blood markers [3 months]

   Immunoglobulins G, M and A in G/l

3. Sport performance [3 months]

   VO2max in mlO2/kg/min determined breath-by-breath on a cycloergometer

4. Sport performance [3 months]

   maximal force of the quadriceps in kg measured on a leg extension machine

Secondary Outcome Measures

1. Body composition [3 months]

   fat mass in kg measured by DEXA

2. Body composition [3 months]

   lean mass in kg measured by DEXA

3. Blood pressure [3 months]

   systolic and diastolic blood pressure in mmHG

Other Outcome Measures

1. Blood markers [3 months]

   red blood cells in 10^6/mm^3

2. Blood markers [3 months]

   haemoglobin in g/dl

3. Blood markers [3 months]

   haematocrit in %

4. Blood markers [3 months]

   iron in ug/dl

5. Blood markers [3 months]

   ferritin in ug/l

6. Blood markers [3 months]

   glycated haemoglobin in %

7. Blood markers [3 months]

   creatine kinase in U/l

8. Blood markers [3 months]

   total cholesterol in mg/dl

9. Blood markers [3 months]

   reticulocytes in %

10. Weight [3 months]

    in kg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLouvain	Louvain-la-Neuve	Brabant Wallon	Belgium	1348

Sponsors and Collaborators

• Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT05815615
• Other Study ID Numbers: RK2020
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Inflammation

Study Results

No Results Posted as of Apr 18, 2023