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

University of Cambridge50,000 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

50,000

Conditions

Blood Donation

Interventions

Reduced versus standard intervals between blood donationsOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (25)

Brentwood Blood Donor Centre

Brentwood, Essex, United Kingdom

Outcomes

Primary Outcomes

Total blood collected after two years

Expressed in units (470ml) per person per year

Time frame: 24 months

Secondary Outcomes

Donor quality of life

Measured using the SF-36 health survey

Time frame: 24 months

Number of donation deferrals

Temporary rejection of donors due to low haemoglobin and other factors

Time frame: 24 months

Markers of iron status

Serum ferritin and reticulocyte haemoglobin

Time frame: 24 months

Cognitive ability

Reasoning, attention and memory

Time frame: 24 months

Levels of physical activity

Time frame: 24 months

Cost effectiveness

Time frame: 24 months

Donor attitudes, beliefs and values

Time frame: 24 months

Data from ClinicalTrials.gov

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