Immunoglobulin deficiency Low immunity
Conditions
Interventions
Donors will be randomly assigned to one of five groups: 1) plasma donation once after 16 weeks, 2) donation every 8 weeks, 3) donation every 4 weeks, 4) donation every 2 weeks, 5) donation ever week.
Sponsors
Sanquin Bloedvoorziening
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Between 18 and 79 years of age; Have a good understanding of the Dutch language; Approved for direct plasma donation during the donor eligibility assessment, conform Sanquin standard operating procedures;Have not donated plasma for at least 3 months, or blood for 6 months[SS1] ; Willing to be randomly assigned into one of the five study arms and donate at the allocated frequency for the duration of the study;Willing to donate plasma only at the Sanquin Powerbank in Utrecht for the duration of the study.
Exclusion criteria
Exclusion criteria: Inability to provide an email address and phone number for study correspondence;Inability to use a personal electronic device to complete questionnaires;Inability to provide informed consent; Has been pregnant, given birth, or breastfed within the past six months;Is foreseeing a pregnancy within the study term;Is foreseeing a period of inaccessibility within the study term (travel; tattoo; etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the impact of different plasmapheresis frequencies on donor immunoglobulin biomarker levels | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are general health, biomarker levels, frequent plasma donation related symptoms such as fatigue and cognitive functioning, donation experiences, and retention and compliance rates. | — |
Countries
Netherlands
Contacts
Public ContactK. van den Hurk
Sanquin Bloedvoorziening
Outcome results
None listed