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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised Trial to Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased

Conditions
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Blood Donation

Intervention / Treatment
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* Other: Reduced versus standard intervals between blood donations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Male - 8 weeks<br>Male donors assigned to an 8 week donation interval frequency | Other: Reduced versus standard intervals between blood donations<br>* 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.<br>|
| Experimental: Male - 10 weeks<br>Male donors assigned to 10 week donation interval frequency | Other: Reduced versus standard intervals between blood donations<br>* 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.<br>|
| No Intervention: Male - 12 weeks<br>Male donors assigned to 12 week donation interval frequency | |
| Experimental: Female - 12 weeks<br>Female donors assigned to 12 week donation interval frequency | Other: Reduced versus standard intervals between blood donations<br>* 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.<br>|
| Experimental: Female - 14 weeks<br>Female donors assigned to 14 week donation interval frequency | Other: Reduced versus standard intervals between blood donations<br>* 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.<br>|
| No Intervention: Female - 16 weeks<br>Female donors assigned to 16 week donation interval frequency | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total blood collected after two years | Expressed in units (470ml) per person per year | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Donor quality of life | Measured using the SF-36 health survey | 24 months | 
| Number of donation deferrals | Temporary rejection of donors due to low haemoglobin and other factors | 24 months | 
| Markers of iron status | Serum ferritin and reticulocyte haemoglobin | 24 months | 
| Cognitive ability | Reasoning, attention and memory | 24 months | 
| Levels of physical activity |  | 24 months | 
| Cost effectiveness |  | 24 months | 
| Donor attitudes, beliefs and values |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, blood donation frequency, quality of life, iron deficiency