Blood Donation
Conditions
Keywords
RCT, blood donation frequency, quality of life, iron deficiency
Brief summary
It is hypothesised that the number of donations made by English blood donors will be greater with reduced vs. standard inter-donation intervals. The null hypothesis is that there will be no difference in donations between treatment groups; this may arise if reduced inter-donation intervals result in a greater number of donation deferrals (due to low haemoglobin) and/or an unacceptable burden to donors.
Detailed description
50,000 blood donors will be recruited from permanent blood donation centres across England to compare different intervals between blood donations to try to find the optimum interval for which it is safe for different donors to give blood. The study will look at whether intervals should be tailored by age, gender, genetic profile, and other characteristics. Study findings should help to improve the well-being of future blood donors in England and enhance the country's blood supplies.
Interventions
OTHERReduced versus standard intervals between blood donations
Over a period of two years participants will be invited to give blood either at usual donation intervals or more frequently. Men will be invited to donate every 12, 10 or 8 weeks and women every 16, 14 or 12 weeks.
Sponsors
National Health Service, Blood and Transplant
University of Oxford
University of Cambridge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18 years or older and fulfilling all normal criteria for blood donation 2. Willing to be assigned to any of the study intervention groups 3. Registered at one of the permanent donation clinics at the time of enrolment
Exclusion criteria
* As the aim of the study is to be almost paper-less, it will involve remote web-based data collection. Hence, participants who do not have internet access and/or are not willing to provide an email address for study correspondence will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total blood collected after two years | 24 months | Expressed in units (470ml) per person per year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Markers of iron status | 24 months | Serum ferritin and reticulocyte haemoglobin |
| Cognitive ability | 24 months | Reasoning, attention and memory |
| Levels of physical activity | 24 months | — |
| Number of donation deferrals | 24 months | Temporary rejection of donors due to low haemoglobin and other factors |
| Donor attitudes, beliefs and values | 24 months | — |
| Donor quality of life | 24 months | Measured using the SF-36 health survey |
| Cost effectiveness | 24 months | — |
Countries
United Kingdom
Outcome results
None listed