INTERVAL Study: To Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased

Not Applicable

• Conditions: Blood Donation

• 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.

Study Timeline

• Study First Submitted: 2012-05-31
• Study Start: 2012-06
• Study First Submitted QC: 2012-06-01
• Study First Posted: 2012-06-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-09
• Last Update Posted: 2015-06-10
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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
Donor quality of life	24 months	Measured using the SF-36 health survey
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

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