Plasma donor health Other
Conditions
Interventions
Three interventions in the domains of ‘frequency’, ‘volume’, and ‘behaviour’ will be tested. The ‘frequency’ intervention will assess the effects of three inter-donation intervals. The ‘volume’ interv
Sponsors
University of Cambridge
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years and fulfilling all normal criteria for plasmapheresis donation. 2. Willing to be assigned to any of the study’s intervention groups and donate at those intervals for the study period. 3. Willing to donate at one of the donation centres for the duration of the study.
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total plasma volume collected over one year will be expressed in millilitres per person per year. There will be no missing data for this outcome. Intervention effects will be assessed as differences in means between randomised groups (usual volume vs enhanced volume, inter-donation intervals and appointment booking method) using linear regression model adjusted for any significant two-way interactions of interventions. Subsidiary analyses will adjust for baseline characteristics (centre, sex, age). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Donors’ well-being will be assessed by using a questionnaire at the baseline, during the study, and at the end of the study. The questionnaires assess donors’ general physical and mental health, cognitive function, motivation for plasma donation, and their personality. 2. Clinical adverse outcomes will be recorded in NHSBT PULSE system during the study. Differences in incidence of vasovagal reactions, citrate toxicity, other serious events, and all adverse events will be compared between randomised groups using logistic regression model. 3. Laboratory markers will be assessed using blood samples taken from donors during procedures. The markers of interest are all items in full blood count, total protein, albumin, and Ig. Differences in means of these markers will be compared between randomised groups using linear regression model. 4. Interim analyses will be performed at 26 weeks to ensure donors’ safety and to provide a prompt feed-back to this ever-changing programme. The outcome of the interim analyses will be the total plasma collected and number of adverse clinical outcomes recorded. Comparisons will be made according to allocated volume and frequency of donation. | — |
Countries
England, United Kingdom
Contacts
Public ContactElisha;Shannon Johnson;Duthie
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Outcome results
None listed