INTERVAL study: To determine whether the interval between blood donations in England can be safely and acceptably decreased

Not Applicable

• Conditions: Optimum intervals for blood donation; Not Applicable

• Registration Number: ISRCTN24760606
• Lead Sponsor: HS Blood and Transplant (NHSBT) (UK)

Brief Summary

2014 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/25230735 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27645285 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28941948 2019 extension study results in: https://www.ncbi.nlm.nih.gov/pubmed/31383583 (added 07/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-25
• Last Update Posted: 16 September 2019
• Study Completion: 2021-11-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50000

Inclusion Criteria

1. Age >17 years 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

Current exclusion criteria as of 22/05/2012:
1. 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

Previous exclusion criteria:
1. Donors who are providing extra samples to NHSBT at their initial visit (e.g. for the British bone marrow registry) as there will be insufficient blood left in the sample pouch for the collection of study samples
2. 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
3. Donors who have been identified for ?special panels? by NHSBT

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total blood collected after two years, expressed in units (470ml) per person per year

Secondary Outcome Measures

Name	Time	Method
<br> Assessed two years after recruitment and will include:<br> 1. Donor quality of life using the SF-36 health survey (this is the key secondary outcome)<br> 2. Number of donation 'deferrals' (i.e. temporary rejections) of donors due to low haemoglobin and other factors<br> 3. Markers of iron status (serum ferritin and reticulocyte haemoglobin)<br> 4. Cognitive ability (reasoning, attention and memory)<br> 5. Levels of physical activity<br> 6. Cost effectiveness<br> 7. Donor attitudes, beliefs and values<br>