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

U

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)

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

Trial contacts and locations

25

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Data sourced from clinicaltrials.gov

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