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

作者：Emanuele Di Angelantonio, Simon G. Thompson, Stephen K. Kaptoge, Carmel S. Moore, Matthew R. Walker, Jane Armitage, Willem Hendrik Ouwehand, David J. Roberts, John Danesh, Emanuele Di Angelantonio, Simon G. Thompson, Stephen K. Kaptoge, Carmel S. Moore, Matthew R. Walker, Jane Armitage, Willem Hendrik Ouwehand, David J. Roberts, John Danesh, Jane Armitage, John Danesh, Emanuele Di Angelantonio, Jenny Donovan, Ian Ford, Rachel A. Henry, Beverley Jane Hunt, Bridget le Huray, Susan Mehenny, Gail Miflin, Carmel S. Moore, Willem Hendrik Ouwehand, Jane Green, David J. Roberts, Mike Stredder, Simon G. Thompson, Matthew R. Walker, Nicholas A. Watkins, Alan McDermott, Clive Ronaldson, Claire Thomson, Zoe Tolkien, Lorna M. Williamson, David L. Allen, John Danesh, Emanuele Di Angelantonio, Rachel A. Henry, Susan Mehenny, Carmel S. Moore, Willem Hendrik Ouwehand, David J. Roberts, Jennifer Sambrook, Matthew R. Walker, Tracey Hammerton, Claire Thomson, Zoe Tolkien, David L. Allen, David G. Bruce, Fizzah Choudry, Emanuele Di Angelantonio, Cédric Ghevaert, Kirstie Johnston, Anne M. Kelly, Andrew R. King, Susan Mehenny, Gail Miflin, Alfred Mo, Carmel S. Moore, Willem Hendrik Ouwehand, Lizanne Page, Penny Richardson, David J. Roberts, Jennifer Sambrook, Peter Alexander Senior, Yagnesh Umrania, Matthew R. Walker, Henna Wong, Stephen K. Kaptoge, Gavin James Murphy, Adrian C. Newland, Keith Wheatley, Michael Greaves, Marc Turner, Tahir Aziz, Richard A. Brain, Christine Davies, Ruth Turner, Paula Wakeman, Alison Dent, Alan Wakeman, Ben Anthony, Desmond Bland, Will Parrondo, Helen Vincent, Candy Weatherill, Andrea Forsyth, Carol Butterfield, Tracey B. Wright, Karen Ellis, Kirstie Johnston, Pat Poynton, Carolyn Brooks, Emma A. Martin, Lara Littler, Lindsay Williams, Donna Blair, Karen Ackerley, Lynn Woods, Sophie A. Stanley, Gemma Walsh, Gayle Franklin, Cheryl Howath, Sarah S. Sharpe, Deborah Ruth Smith, Lauren Botham, Caroline C. Williams, Claire L. Alexander, Gareth Sowerbutts, Diane Furnival, Michael Thake, Shilpa N. Patel, Carolyn Roost, Sandra Sowerby, Mary Joy Appleton, Eileen Bays, Geoff Bowyer, Steven G. Clarkson, Stuart Halson, Kate Holmes, Gareth Humphries, Kirstie Johnston, Lee Parvin-Cooper, Jason Towler, Joanne Addy, Patricia Barrass, Louise Stennett, Susan Burton, Hannah Dingwall, Rachel A. Henry, Victoria Clarke, Maria Potton, Claire Thomson, Thomas Bolton, Michael Daynes, Stuart Halson, Sarah Spackman, Matthew R. Walker, Abudu Momodu, James Fenton, Adam B. King, O A Muhammed, N Oates, Tim Peakman, Christine Ryan, Kristian Spreckley, Craig Stubbins, Joanna G Williams, James M. Brennan, Cedric Mochon, Samantha Taylor, Kimberley Warren, Stephen K. Kaptoge, Simon G. Thompson, Emanuele Di Angelantonio, Carmel S. Moore, Jonathan Mant, Willem Hendrik Ouwehand, Simon G. Thompson, John Danesh, David J. Roberts · 发表于：The Lancet · 年份：2017 · DOI：10.1016/s0140-6736(17)31928-1 · 被引用次数：303 · 研究领域：Blood donation and transfusion practices、Iron Metabolism and Disorders、Blood transfusion and management

BACKGROUND: Limits on the frequency of whole blood donation exist primarily to safeguard donor health. However, there is substantial variation across blood services in the maximum frequency of donations allowed. We compared standard practice in the UK with shorter inter-donation intervals used in other countries. METHODS: In this parallel group, pragmatic, randomised trial, we recruited whole blood donors aged 18 years or older from 25 centres across England, UK. By use of a computer-based algorithm, men were randomly assigned (1:1:1) to 12-week (standard) versus 10-week versus 8-week inter-donation intervals, and women were randomly assigned (1:1:1) to 16-week (standard) versus 14-week versus 12-week intervals. Participants were not masked to their allocated intervention group. The primary outcome was the number of donations over 2 years. Secondary outcomes related to safety were quality of life, symptoms potentially related to donation, physical activity, cognitive function, haemoglobin and ferritin concentrations, and deferrals because of low haemoglobin. This trial is registered with ISRCTN, number ISRCTN24760606, and is ongoing but no longer recruiting participants. FINDINGS: 45 263 whole blood donors (22 466 men, 22 797 women) were recruited between June 11, 2012, and June 15, 2014. Data were analysed for 45 042 (99·5%) participants. Men were randomly assigned to the 12-week (n=7452) versus 10-week (n=7449) versus 8-week (n=7456) groups; and women to the 16-week (n=7550...