Clinical trial NCT01610635: INTERVAL Study: To Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased
Official title: A Randomised Trial to Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Donation
Keywords: RCT
blood donation frequency
quality of life
iron deficiency
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: National Health Service, Blood and Transplant
name: University of Oxford
First posted: 2012-06-04
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total blood collected after two years
timeFrame: 24 months
Secondary outcomes:
measure: Donor quality of life
timeFrame: 24 months
measure: Number of donation deferrals
timeFrame: 24 months
measure: Markers of iron status
timeFrame: 24 months
measure: Cognitive ability
timeFrame: 24 months
measure: Levels of physical activity
timeFrame: 24 months
measure: Cost effectiveness
timeFrame: 24 months
measure: Donor attitudes, beliefs and values
timeFrame: 24 months
Other outcomes:
Locations:
city: Brentwood
country: United Kingdom
facility: Brentwood Blood Donor Centre
state: Essex
city: Edgware
country: United Kingdom
facility: Edgware Blood Donor Centre
state: Middlesex
city: Birmingham
country: United Kingdom
facility: Birmingham Blood Donor Centre
city: Bradford
country: United Kingdom
facility: Bradford Blood Donor Centre
city: Bristol
country: United Kingdom
facility: Bristol Blood Donor Centre
city: Cambridge
country: United Kingdom
facility: Cambridge Blood Donor Centre
city: Gloucester
country: United Kingdom
facility: Gloucester Blood Donor Centre
city: Lancaster
country: United Kingdom
facility: Lancaster Blood Donor Centre
city: Leeds
country: United Kingdom
facility: Leeds City Centre Blood Donor Centre
city: Leeds
country: United Kingdom
facility: Leeds Blood Donor Centre
city: Leicester
country: United Kingdom
facility: Leicester Blood Donor Centre
city: Liverpool
country: United Kingdom
facility: Liverpool Blood Donor Centre
city: London
country: United Kingdom
facility: Tooting Blood Donor Centre
city: London
country: United Kingdom
facility: West End Blood Donor Centre
city: Luton
country: United Kingdom
facility: Luton Blood Donor Centre
city: Manchester
country: United Kingdom
facility: Manchester Plymouth Grove
city: Manchester
country: United Kingdom
facility: Manchester Norfolk House Blood Donor Centre
city: Newcastle
country: United Kingdom
facility: Newcastle Blood Donor Centre
city: Nottingham
country: United Kingdom
facility: Nottingham Blood Donor Centre
city: Oxford
country: United Kingdom
facility: Oxford Blood Donor Centre
city: Plymouth
country: United Kingdom
facility: Plymouth Blood Donor Centre
city: Poole
country: United Kingdom
facility: Poole Blood Donor Centre
city: Sheffield
country: United Kingdom
facility: Sheffield Blood Donor Centre
city: Southampton
country: United Kingdom
facility: Southampton Blood Donor Centre
city: Stoke
country: United Kingdom
facility: Stoke Blood Donor Centre
Study officials:
affiliation: University of Cambridge
name: John Danesh
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: David Roberts
role: PRINCIPAL_INVESTIGATOR
References: