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

Conditions

Optimum intervals for blood donation Not Applicable

Kaptoge S, Di Angelantonio E, Moore C, Walker M, Armitage J, Ouwehand WH, Roberts DJ, Danesh J, Thompson SG, INTERVAL Trial Group.

2019-08-0218 citations

10.1016/s2352-3026(19)30106-1

Efficiency and safety of varying the frequency of whole blood donation (INTERVAL): a randomised trial of 45 000 donors.

Di Angelantonio E, Thompson SG, Kaptoge S, Moore C, Walker M, Armitage J, Ouwehand WH, Roberts DJ, Danesh J, INTERVAL Trial Group.

2017-09-21210 citations

10.1016/s0140-6736(17)31928-1

Recruitment and representativeness of blood donors in the INTERVAL randomised trial assessing varying inter-donation intervals.

Moore C, Bolton T, Walker M, Kaptoge S, Allen D, Daynes M, Mehenny S, Sambrook J, Watkins NA, Miflin G, Di Angelantonio E, Ouwehand WH, Roberts DJ, Danesh J, Thompson SG.

2016-09-2017 citations

10.1186/s13063-016-1579-7

The INTERVAL trial to determine whether intervals between blood donations can be safely and acceptably decreased to optimise blood supply: study protocol for a randomised controlled trial.

Moore C, Sambrook J, Walker M, Tolkien Z, Kaptoge S, Allen D, Mehenny S, Mant J, Di Angelantonio E, Thompson SG, Ouwehand W, Roberts DJ, Danesh J.

2014-09-17118 citations

10.1186/1745-6215-15-363

Interventions

The study will involve 25,000 male and 25,000 female whole blood donors recruited at donation visits to the 25 permanent NHSBT clinics across England. Participation will be over a two-year period.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Total blood collected after two years, expressed in units (470ml) per person per year	—

Secondary

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

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed