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

被引：200

作者：

Di Angelantonio, Emanuele ^{[1
,2
,3
,4
,5
,6
]}

Thompson, Simon G. ^{[3
,4
,5
,6
]}

Kaptoge, Stephen ^{[3
,4
,5
,6
]}

Moore, Carmel ^{[3
,4
,5
,6
]}

Walker, Matthew ^{[3
,4
,5
,6
]}

Armitage, Jane ^{[10
,11
,12
,13
]}

Ouwehand, Willem H. ^{[1
,2
,6
,7
]}

Roberts, David J. ^{[1
,2
,4
,8
,9
]}

Danesh, John ^{[3
,4
,5
]}

机构：

[1] NHS Blood & Transplant, Cambridge, England

[2] NHS Blood & Transplant, Oxford, England

[3] Strangeways Res Lab, Dept Publ Hlth & Primary Care, Cambridge, England

[4] Strangeways Res Lab, NIHR Blood & Transplant Res Unit Donor Hlth & Gen, Cambridge, England

[5] Addenbrookes Hosp, NIHR Cambridge Biomed Res Ctr, Cambridge, England

[6] Addenbrookes Hosp, British Heart Fdn, Cambridge Ctr Res Excellence, Cambridge, England

[7] Univ Cambridge, Dept Haematol, Cambridge Biomed Campus, Cambridge, England

[8] Univ Oxford, John Radcliffe Hosp, NIHR Oxford Biomed Res Ctr Haematol Theme, Oxford, England

[9] Univ Oxford, John Radcliffe Hosp, Radcliffe Dept Med, Oxford, England

[10] Univ Oxford, Clin Trial Serv Unit, Oxford, England

[11] Univ Oxford, Epidemiol Studies Unit, Oxford, England

[12] Univ Oxford, Nuffield Dept Populat Hlth, Oxford, England

[13] Univ Oxford, MRC Populat Hlth Res Unit, Oxford, England

来源：

LANCET | 2017年 / 390卷 / 10110期

基金：

英国医学研究理事会;

关键词：

FORM HEALTH SURVEY; INTERDONATION INTERVAL; INTERNATIONAL FORUM; HEMOGLOBIN CUTOFF; IRON STATUS; AVAILABILITY; GUIDELINES; IMPACT; RETURN; SF-36;

D O I：

10.1016/S0140-6736(17)31928-1

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 45263 whole blood donors (22466 men, 22797 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) versus 14-week (n=7567) versus 12-week (n=7568) groups. In men, compared with the 12-week group, the mean amount of blood collected per donor over 2 years increased by 1.69 units (95% CI 1.59-1.80; approximately 795 mL) in the 8-week group and by 0.79 units (0.69-0.88; approximately 370 mL) in the 10-week group(p<0.0001 for both). In women, compared with the 16-week group, it increased by 0 . 84 units (95% CI 0.76-0.91; approximately 395 mL) in the 12-week group and by 0.46 units (0.39-0.53; approximately 215 mL) in the 14-week group (p<0.0001 for both). No significant differences were observed in quality of life, physical activity, or cognitive function across randomised groups. However, more frequent donation resulted in more donation-related symptoms (eg, tiredness, breathlessness, feeling faint, dizziness, and restless legs, especially among men [for all listed symptoms]), lower mean haemoglobin and ferritin concentrations, and more deferrals for low haemoglobin (p<0.0001 for each) than those observed in the standard frequency groups. Interpretation Over 2 years, more frequent donation than is standard practice in the UK collected substantially more blood without having a major effect on donors' quality of life, physical activity, or cognitive function, but resulted in more donation-related symptoms, deferrals, and iron deficiency. Copyright (C) The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.

引用

页码：2360 / 2371

页数：12

共 37 条

[1]

AABB Association, B 17 02 UPD STRAT LI

[2] Validation of the self-completed Cambridge-Hopkins questionnaire (CH-RLSq) for ascertainment of restless legs syndrome (RLS) in a population survey [J].

Allen, Richard P. ;

Burchell, Brendan J. ;

MacDonald, Ben ;

Hening, Wayne A. ;

Earley, Christopher J. .

SLEEP MEDICINE, 2009, 10 (10) :1097-1100

[3] Minimum donation intervals should be reconsidered to decrease low hemoglobin deferral in whole blood donors: an observational study [J].

Baart, A. Mireille ;

van den Hurk, Katja ;

de Kort, Wim L. A. M. .

TRANSFUSION, 2015, 55 (11) :2641-2644

[4] Donation frequency of blood donors participating in a prospective cohort study of iron status [J].

Bahrami, Shrein H. ;

Guiltinan, Anne M. ;

Schlumpf, Karen S. ;

Scott, Erik ;

Banks, Linda L. ;

D'Andrea, Pam ;

Hartman, Elizabeth L. ;

Vij, Vibha ;

Wright, David J. ;

Spencer, Bryan ;

Murphy, Edward L. .

TRANSFUSION, 2011, 51 (06) :1207-1212

[5] Clinical Practice Guidelines From the AABB Red Blood Cell Transfusion Thresholds and Storage [J].

Carson, Jeffrey L. ;

Guyatt, Gordon ;

Heddle, Nancy M. ;

Grossman, Brenda J. ;

Cohn, Claudia S. ;

Fung, Mark K. ;

Gernsheimer, Terry ;

Holcomb, John B. ;

Kaplan, Lewis J. ;

Katz, Louis M. ;

Peterson, Nikki ;

Ramsey, Glenn ;

Rao, Sunil V. ;

Roback, John D. ;

Shander, Aryeh ;

Tobian, Aaron A. R. .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2016, 316 (19) :2025-2035

[6] The consequences of temporary deferral on future whole blood donation [J].

Custer, Brian ;

Chinn, Artina ;

Hirschler, Nora V. ;

Busch, Michael P. ;

Murphy, Edward L. .

TRANSFUSION, 2007, 47 (08) :1514-1523

[7] Genome-wide association study of cognitive functions and educational attainment in UK Biobank (N=112151) [J].

Davies, G. ;

Marioni, R. E. ;

Liewald, D. C. ;

Hill, W. D. ;

Hagenaars, S. P. ;

Harris, S. E. ;

Ritchie, S. J. ;

Luciano, M. ;

Fawns-Ritchie, C. ;

Lyall, D. ;

Cullen, B. ;

Cox, S. R. ;

Hayward, C. ;

Porteous, D. J. ;

Evans, J. ;

McIntosh, A. M. ;

Gallacher, J. ;

Craddock, N. ;

Pell, J. P. ;

Smith, D. J. ;

Gale, C. R. ;

Deary, I. J. .

MOLECULAR PSYCHIATRY, 2016, 21 (06) :758-767

[8] Effect of increasing hemoglobin cutoff in male donors and increasing interdonation interval in whole blood donors at a hospital-based blood donor center [J].

Gandhi, Manish J. ;

Duffy, Kimberly ;

Benike, Mary ;

Jenkins, Sarah ;

Stubbs, James R. .

TRANSFUSION, 2012, 52 (09) :1880-1888

[9] International Forum regarding practices related to donor haemoglobin and iron [J].

Goldman, M. ;

Magnussen, K. ;

Gorlin, J. ;

Lozano, M. ;

Speedy, J. ;

Keller, A. ;

Pink, J. ;

Leung, J. N. S. ;

Chu, C. C. Y. ;

Lee, C. -K. ;

Faed, J. ;

Chay, J. ;

Tan, H. H. ;

Teo, D. ;

Djoudi, R. ;

Woimant, G. ;

Fillet, A. -M. ;

Castren, J. ;

Miflin, G. ;

Vandewalle, G. C. ;

Compernolle, V. ;

Cardenas, J. M. ;

Infanti, L. ;

Holbro, A. ;

Buser, A. ;

van den Hurk, K. ;

Yahalom, V. J. ;

Gendelman, V. ;

Shinar, E. ;

Eder, A. F. ;

Steele, W. R. ;

O'Neill, E. M. ;

Kamel, H. ;

Vassallo, R. ;

Delage, G. ;

Lebrun, A. ;

Robillard, P. ;

Germain, M. ;

Gandhi, M. ;

West, K. A. ;

Klein, H. G. .

VOX SANGUINIS, 2016, 111 (04) :449-473

[10] A large national study of ferritin testing in Canadian blood donors [J].

Goldman, Mindy ;

Uzicanin, Samra ;

Osmond, Lori ;

Scalia, Vito ;

O'Brien, Sheila F. .

TRANSFUSION, 2017, 57 (03) :564-570

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