Overview

This trial is active, not recruiting.

Condition blood donation
Treatment reduced versus standard intervals between blood donations
Sponsor University of Cambridge
Collaborator National Health Service, Blood and Transplant
Start date June 2012
End date June 2016
Trial size 50000 participants
Trial identifier NCT01610635, 11-01-GEN, 24760606

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Male donors assigned to an 8 week donation interval frequency
reduced versus standard intervals between blood donations
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.
(Experimental)
Male donors assigned to 10 week donation interval frequency
reduced versus standard intervals between blood donations
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.
(No Intervention)
Male donors assigned to 12 week donation interval frequency
(Experimental)
Female donors assigned to 12 week donation interval frequency
reduced versus standard intervals between blood donations
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.
(Experimental)
Female donors assigned to 14 week donation interval frequency
reduced versus standard intervals between blood donations
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.
(No Intervention)
Female donors assigned to 16 week donation interval frequency

Primary Outcomes

Measure
Total blood collected after two years
time frame: 24 months

Secondary Outcomes

Measure
Donor quality of life
time frame: 24 months
Number of donation deferrals
time frame: 24 months
Markers of iron status
time frame: 24 months
Cognitive ability
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Randomised Trial to Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased
Principal investigator John Danesh
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of Cambridge.