Blood Donation Clinical Trial
— INTERVALOfficial title:
A Randomised Trial to Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased
Verified date | June 2015 |
Source | University of Cambridge |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 50000 |
Est. completion date | December 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United Kingdom | Birmingham Blood Donor Centre | Birmingham | |
United Kingdom | Bradford Blood Donor Centre | Bradford | |
United Kingdom | Brentwood Blood Donor Centre | Brentwood | Essex |
United Kingdom | Bristol Blood Donor Centre | Bristol | |
United Kingdom | Cambridge Blood Donor Centre | Cambridge | |
United Kingdom | Edgware Blood Donor Centre | Edgware | Middlesex |
United Kingdom | Gloucester Blood Donor Centre | Gloucester | |
United Kingdom | Lancaster Blood Donor Centre | Lancaster | |
United Kingdom | Leeds Blood Donor Centre | Leeds | |
United Kingdom | Leeds City Centre Blood Donor Centre | Leeds | |
United Kingdom | Leicester Blood Donor Centre | Leicester | |
United Kingdom | Liverpool Blood Donor Centre | Liverpool | |
United Kingdom | Tooting Blood Donor Centre | London | |
United Kingdom | West End Blood Donor Centre | London | |
United Kingdom | Luton Blood Donor Centre | Luton | |
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 | Oxford Blood Donor Centre | Oxford | |
United Kingdom | Plymouth Blood Donor Centre | Plymouth | |
United Kingdom | Poole Blood Donor Centre | Poole | |
United Kingdom | Sheffield Blood Donor Centre | Sheffield | |
United Kingdom | Southampton Blood Donor Centre | Southampton | |
United Kingdom | Stoke Blood Donor Centre | Stoke |
Lead Sponsor | Collaborator |
---|---|
University of Cambridge | National Health Service, Blood and Transplant, University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total blood collected after two years | Expressed in units (470ml) per person per year | 24 months | No |
Secondary | Donor quality of life | Measured using the SF-36 health survey | 24 months | Yes |
Secondary | Number of donation deferrals | Temporary rejection of donors due to low haemoglobin and other factors | 24 months | Yes |
Secondary | Markers of iron status | Serum ferritin and reticulocyte haemoglobin | 24 months | Yes |
Secondary | Cognitive ability | Reasoning, attention and memory | 24 months | Yes |
Secondary | Levels of physical activity | 24 months | Yes | |
Secondary | Cost effectiveness | 24 months | No | |
Secondary | Donor attitudes, beliefs and values | 24 months | No |
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