NCT05815615

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

March 20, 2023

Last Update Submit

April 3, 2023

Conditions

PlasmapheresisHaematologySport PerformanceBody CompositionInflammationImmunologyAdverse Events

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Body composition

    3 months

  • Body composition

    3 months

  • Blood pressure

    3 months

Other Outcomes (10)

  • Blood markers

    3 months

  • Blood markers

    3 months

  • Blood markers

    3 months

  • +7 more other outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Simulated plasma donation, same procedure as for plasmapheresis but without drawing blood.

Device: Plasmapheresis

Low-frequency

EXPERIMENTAL

Plasma donation 1x/month for 3 months

Device: Plasmapheresis

High-frequency

EXPERIMENTAL

Plasma donation 3x/month for 3 months

Device: Plasmapheresis

US scheme

EXPERIMENTAL

Plasma donation 2x/week for 3 months

Device: Plasmapheresis

Interventions

PlasmapheresisDEVICE

Plasma donation at different frequencies

High-frequencyLow-frequencyPlaceboUS scheme

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLouvain

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

Location

MeSH Terms

Conditions

Inflammation

Interventions

Plasmapheresis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Component RemovalTherapeuticsSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 18, 2023

Study Start

March 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)