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

University of Cambridge

Status: Unknown

Conditions: Blood Donation

Treatments: Other: Reduced versus standard intervals between blood donations

Study type: Interventional

Funder types: Other

Identifiers

NCT01610635

24760606 (Other Identifier)

11-01-GEN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50,000 participants in 6 patient groups

Male - 8 weeks

Experimental group

Description:

Male donors assigned to an 8 week donation interval frequency

Treatment:

Other: Reduced versus standard intervals between blood donations

Male - 10 weeks

Experimental group

Description:

Male donors assigned to 10 week donation interval frequency

Treatment:

Other: Reduced versus standard intervals between blood donations

Male - 12 weeks

No Intervention group

Description:

Male donors assigned to 12 week donation interval frequency

Female - 12 weeks

Experimental group

Description:

Female donors assigned to 12 week donation interval frequency

Treatment:

Other: Reduced versus standard intervals between blood donations

Female - 14 weeks

Experimental group

Description:

Female donors assigned to 14 week donation interval frequency

Treatment:

Other: Reduced versus standard intervals between blood donations

Female - 16 weeks

No Intervention group

Description:

Female donors assigned to 16 week donation interval frequency