title: 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.
abstract: BACKGROUND
  Ageing populations may demand more blood transfusions, but the blood supply could be limited by difficulties in attracting and retaining a decreasing pool of younger donors. One approach to increase blood supply is to collect blood more frequently from existing donors. If more donations could be safely collected in this manner at marginal cost, then it would be of considerable benefit to blood services. National Health Service (NHS) Blood and Transplant in England currently allows men to donate up to every 12 weeks and women to donate up to every 16 weeks. In contrast, some other European countries allow donations as frequently as every 8 weeks for men and every 10 weeks for women. The primary aim of the INTERVAL trial is to determine whether donation intervals can be safely and acceptably decreased to optimise blood supply whilst maintaining the health of donors.
  
  
  METHODS
  INTERVAL is a randomised trial of whole blood donors enrolled from all 25 static centres of NHS Blood and Transplant. Recruitment of about 50,000 male and female donors started in June 2012 and was completed in June 2014. Men have been randomly assigned to standard 12-week versus 10-week versus 8-week inter-donation intervals, while women have been assigned to standard 16-week versus 14-week versus 12-week inter-donation intervals. Sex-specific comparisons will be made by intention-to-treat analysis of outcomes assessed after two years of intervention. The primary outcome is the number of blood donations made. A key secondary outcome is donor quality of life, assessed using the Short Form Health Survey. Additional secondary endpoints include the number of 'deferrals' due to low haemoglobin (and other factors), iron status, cognitive function, physical activity, and donor attitudes. A comprehensive health economic analysis will be undertaken.
  
  
  CONCLUSIONS
  The INTERVAL trial should yield novel information about the effect of inter-donation intervals on blood supply, acceptability, and donors' physical and mental well-being. The study will generate scientific evidence to help formulate blood collection policies in England and elsewhere.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN24760606, 25 January 2012.
authors.forename: Carmel
authors.initials: C
authors.lastname: Moore
authors.forename: Jennifer
authors.initials: J
authors.lastname: Sambrook
authors.forename: Matthew
authors.initials: M
authors.lastname: Walker
authors.forename: Zoe
authors.initials: Z
authors.lastname: Tolkien
authors.forename: Stephen
authors.initials: S
authors.lastname: Kaptoge
authors.forename: David
authors.initials: D
authors.lastname: Allen
authors.forename: Susan
authors.initials: S
authors.lastname: Mehenny
authors.forename: Jonathan
authors.initials: J
authors.lastname: Mant
authors.forename: Emanuele
authors.initials: E
authors.lastname: Di Angelantonio
authors.forename: Simon G
authors.initials: SG
authors.lastname: Thompson
authors.forename: Willem
authors.initials: W
authors.lastname: Ouwehand
authors.forename: David J
authors.initials: DJ
authors.lastname: Roberts
authors.affiliation: Department of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, Worts Causeway, Cambridge CB1 8RN, UK. interval@medschl.cam.ac.uk.
authors.forename: John
authors.initials: J
authors.lastname: Danesh
mesh_terms: D001782:Blood Donors / Q000523:psychology / Q000600:supply & distribution*; D001803:Blood Transfusion; D002985:Clinical Protocols; D046148:Donor Selection / Q000379:methods*; D004739:England; D005260:Female; D006304:Health Status; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D011788:Quality of Life; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors