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

Blood Donation Clinical Trial

— INTERVAL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01610635
• Other study ID #: 11-01-GEN
• Secondary ID: 24760606
• Status: Active, not recruiting
• Phase: N/A
• First received: May 31, 2012
• Last updated: June 9, 2015
• Start date: June 2012
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50000
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Blood Donation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	Birmingham Blood Donor Centre	Birmingham
United Kingdom	Bradford Blood Donor Centre	Bradford
United Kingdom	Brentwood Blood Donor Centre	Brentwood	Essex
United Kingdom	Bristol Blood Donor Centre	Bristol
United Kingdom	Cambridge Blood Donor Centre	Cambridge
United Kingdom	Edgware Blood Donor Centre	Edgware	Middlesex
United Kingdom	Gloucester Blood Donor Centre	Gloucester
United Kingdom	Lancaster Blood Donor Centre	Lancaster
United Kingdom	Leeds Blood Donor Centre	Leeds
United Kingdom	Leeds City Centre Blood Donor Centre	Leeds
United Kingdom	Leicester Blood Donor Centre	Leicester
United Kingdom	Liverpool Blood Donor Centre	Liverpool
United Kingdom	Tooting Blood Donor Centre	London
United Kingdom	West End Blood Donor Centre	London
United Kingdom	Luton Blood Donor Centre	Luton
United Kingdom	Manchester Norfolk House Blood Donor Centre	Manchester
United Kingdom	Manchester Plymouth Grove	Manchester
United Kingdom	Newcastle Blood Donor Centre	Newcastle
United Kingdom	Nottingham Blood Donor Centre	Nottingham
United Kingdom	Oxford Blood Donor Centre	Oxford
United Kingdom	Plymouth Blood Donor Centre	Plymouth
United Kingdom	Poole Blood Donor Centre	Poole
United Kingdom	Sheffield Blood Donor Centre	Sheffield
United Kingdom	Southampton Blood Donor Centre	Southampton
United Kingdom	Stoke Blood Donor Centre	Stoke

Sponsors (3)

Lead Sponsor	Collaborator
University of Cambridge	National Health Service, Blood and Transplant, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total blood collected after two years	Expressed in units (470ml) per person per year	24 months	No
Secondary	Donor quality of life	Measured using the SF-36 health survey	24 months	Yes
Secondary	Number of donation deferrals	Temporary rejection of donors due to low haemoglobin and other factors	24 months	Yes
Secondary	Markers of iron status	Serum ferritin and reticulocyte haemoglobin	24 months	Yes
Secondary	Cognitive ability	Reasoning, attention and memory	24 months	Yes
Secondary	Levels of physical activity		24 months	Yes
Secondary	Cost effectiveness		24 months	No
Secondary	Donor attitudes, beliefs and values		24 months	No

External Links

•   INTERVAL study webpage
•   UK Clinical Trials Gateway study record