INTERVAL Study: To Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased
- Conditions
- Blood Donation
- Interventions
- Other: Reduced versus standard intervals between blood donations
- Registration Number
- NCT01610635
- Lead Sponsor
- University of Cambridge
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50000
- Aged 18 years or older and fulfilling all normal criteria for blood donation
- Willing to be assigned to any of the study intervention groups
- Registered at one of the permanent donation clinics at the time of enrolment
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Male - 8 weeks Reduced versus standard intervals between blood donations Male donors assigned to an 8 week donation interval frequency Male - 10 weeks Reduced versus standard intervals between blood donations Male donors assigned to 10 week donation interval frequency Female - 14 weeks Reduced versus standard intervals between blood donations Female donors assigned to 14 week donation interval frequency Female - 12 weeks Reduced versus standard intervals between blood donations Female donors assigned to 12 week donation interval frequency
- Primary Outcome Measures
Name Time Method Total blood collected after two years 24 months Expressed in units (470ml) per person per year
- Secondary Outcome Measures
Name Time Method Donor quality of life 24 months Measured using the SF-36 health survey
Levels of physical activity 24 months Cost effectiveness 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 Cognitive ability 24 months Reasoning, attention and memory
Markers of iron status 24 months Serum ferritin and reticulocyte haemoglobin
Trial Locations
- Locations (25)
Brentwood Blood Donor Centre
🇬🇧Brentwood, Essex, United Kingdom
Edgware Blood Donor Centre
🇬🇧Edgware, Middlesex, United Kingdom
Birmingham Blood Donor Centre
🇬🇧Birmingham, United Kingdom
Bradford Blood Donor Centre
🇬🇧Bradford, United Kingdom
Bristol Blood Donor Centre
🇬🇧Bristol, United Kingdom
Cambridge Blood Donor Centre
🇬🇧Cambridge, United Kingdom
Gloucester Blood Donor Centre
🇬🇧Gloucester, United Kingdom
Lancaster Blood Donor Centre
🇬🇧Lancaster, United Kingdom
Leeds City Centre Blood Donor Centre
🇬🇧Leeds, United Kingdom
Leeds Blood Donor Centre
🇬🇧Leeds, United Kingdom
Liverpool Blood Donor Centre
🇬🇧Liverpool, United Kingdom
Leicester Blood Donor Centre
🇬🇧Leicester, United Kingdom
Tooting Blood Donor Centre
🇬🇧London, United Kingdom
Luton Blood Donor Centre
🇬🇧Luton, United Kingdom
West End Blood Donor Centre
🇬🇧London, United Kingdom
Manchester Norfolk House Blood Donor Centre
🇬🇧Manchester, United Kingdom
Manchester Plymouth Grove
🇬🇧Manchester, United Kingdom
Newcastle Blood Donor Centre
🇬🇧Newcastle, United Kingdom
Nottingham Blood Donor Centre
🇬🇧Nottingham, United Kingdom
Plymouth Blood Donor Centre
🇬🇧Plymouth, United Kingdom
Oxford Blood Donor Centre
🇬🇧Oxford, United Kingdom
Sheffield Blood Donor Centre
🇬🇧Sheffield, United Kingdom
Southampton Blood Donor Centre
🇬🇧Southampton, United Kingdom
Stoke Blood Donor Centre
🇬🇧Stoke, United Kingdom
Poole Blood Donor Centre
🇬🇧Poole, United Kingdom