Plasmapheresis: a Multi-modal Approach

Study of the Side Effects of Plasmapheresis: a Multi-modal Approach

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Body Composition; Immunology; Adverse Events; Plasmapheresis; Sport Performance; Haematology
• Intervention / Treatment: Device: Plasmapheresis

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brabant Wallon
    • Louvain-la-Neuve, Brabant Wallon, Belgium, 1348
      • UCLouvain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Blood pressure	systolic and diastolic blood pressure in mmHG	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood markers	red blood cells in 10^6/mm^3	3 months
Blood markers	haemoglobin in g/dl	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

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: RK2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No