{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T15:07:53Z","timestamp":1760800073848,"version":"3.37.3"},"reference-count":74,"publisher":"National Institute for Health and Care Research","issue":"62","license":[{"start":{"date-parts":[[2017,10,1]],"date-time":"2017-10-01T00:00:00Z","timestamp":1506816000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["09\/144\/51"],"award-info":[{"award-number":["09\/144\/51"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000024","name":"Canadian Institutes of Health Research","doi-asserted-by":"publisher","award":["177453"],"award-info":[{"award-number":["177453"]}],"id":[{"id":"10.13039\/501100000024","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000156","name":"Fonds de Recherche du Qu\u00e9bec - Sant\u00e9","doi-asserted-by":"publisher","award":["24460"],"award-info":[{"award-number":["24460"]}],"id":[{"id":"10.13039\/501100000156","id-type":"DOI","asserted-by":"publisher"}]},{"name":"The French Ministry of Health Programme Hospitalier de Recherche Clinique","award":["12.07, 2011"],"award-info":[{"award-number":["12.07, 2011"]}]},{"name":"\u00c9tablissement Fran\u00e7ais du Sang and Sanquin Blood Supply"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title><jats:p>At present, red blood cells (RBCs) are stored for up to 42 days prior to transfusion. The relative effectiveness and safety of different RBC storage times prior to transfusion is uncertain.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-2\"><jats:title>Objective<\/jats:title><jats:p>To assess the clinical effectiveness and cost-effectiveness of transfusing fresher RBCs (stored for \u2264\u20097 days) compared with current standard-aged RBCs in critically ill patients requiring blood transfusions.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-3\"><jats:title>Design<\/jats:title><jats:p>The international Age of BLood Evaluation (ABLE) trial was a multicentre, randomised, blinded trial undertaken in Canada, the UK, the Netherlands and France. The UK trial was funded to contribute patients to the international trial and undertake a UK-specific health economic evaluation.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-4\"><jats:title>Setting<\/jats:title><jats:p>Twenty intensive care units (ICUs) in the UK, as part of 64 international centres.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-5\"><jats:title>Participants<\/jats:title><jats:p>Critically ill patients aged \u2265\u200918 years (\u2265\u200916 years in Scotland) expected to require mechanical ventilation for \u2265\u200948 hours and requiring a first RBC transfusion during the first 7 days in the ICU.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-6\"><jats:title>Interventions<\/jats:title><jats:p>All decisions to transfuse RBCs were made by clinicians. One patient group received exclusively fresh RBCs stored for \u2264\u20097 days whenever transfusion was required from randomisation until hospital discharge. The other group received standard-issue RBCs throughout their hospital stay.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-7\"><jats:title>Main outcome measures<\/jats:title><jats:p>The primary outcome was 90-day mortality. Secondary outcomes included development of organ dysfunction, new thrombosis, infections and transfusion reactions. The primary economic evaluation was a cost\u2013utility analysis.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-8\"><jats:title>Results<\/jats:title><jats:p>The international trial took place between March 2009 and October 2014 (UK recruitment took place between January 2012 and October 2014). In total, 1211 patients were assigned to receive fresh blood and 1219 patients to receive standard-aged blood. RBCs were stored for a mean of 6.1 days [standard deviation (SD) \u00b1\u20094.9 days] in the group allocated to receive fresh blood and 22.0 days (SD\u2009\u00b1\u20098.4 days) in the group allocated to receive standard-aged blood. Patients received a mean of 4.3\u2009RBC units (SD\u2009\u00b1\u20095.2\u2009RBC units) and 4.3\u2009RBC units (SD\u2009\u00b1\u20095.5\u2009RBC units) in the groups receiving fresh blood and standard-aged blood, respectively. At 90 days, 37.0% of patients in the group allocated to receive fresh blood and 35.3% of patients in the group allocated to receive standard-aged blood had died {absolute risk difference 1.7% [95% confidence interval (CI) \u20132.1% to 5.5%]}. There were no between-group differences in any secondary outcomes. The UK cohort comprised 359 patients randomised and followed up for 12 months for the cost\u2013utility analysis. UK patients had similar characteristics and outcomes to the international cohort. Mean total costs per patient were \u00a332,346 (95% CI \u00a329,306 to \u00a335,385) in the group allocated to receive fresh blood and \u00a333,353 (95% CI \u00a329,729 to \u00a336,978) in the group allocated to receive standard-aged blood. Approximately 85% of the total costs were incurred during the index hospital admission. There were no significant cost differences between the two groups [mean incremental costs for those receiving fresh vs. standard-aged blood: \u2013\u00a3231 (95% CI \u2013\u00a34876 to \u00a34415)], nor were there significant differences in outcomes (mean difference in quality-adjusted life-years \u20130.010, 95% CI \u20130.078 to 0.057).<\/jats:p><\/jats:sec><jats:sec id=\"abs1-9\"><jats:title>Limitations<\/jats:title><jats:p>Adverse effects from the exclusive use of older RBCs compared with standard or fresh RBCs cannot be excluded.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-10\"><jats:title>Conclusions<\/jats:title><jats:p>The use of RBCs aged \u2264\u20097 days confers no clinical or economic benefit in critically ill patients compared with standard-aged RBCs.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-11\"><jats:title>Future work<\/jats:title><jats:p>Future studies should address the safety of RBCs near the end of the current permitted storage age.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-12\"><jats:title>Trial registration<\/jats:title><jats:p>Current Controlled Trials ISRCTN44878718.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-13\"><jats:title>Funding<\/jats:title><jats:p>This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in<jats:italic>Health Technology Assessment<\/jats:italic>; Vol. 21, No. 62. See the NIHR Journals Library website for further project information. The international ABLE trial was also supported by peer-reviewed grants from the Canadian Institutes of Health Research (177453), Fonds de Recherche du Qu\u00e9bec - Sant\u00e9 (24460), the French Ministry of Health Programme Hospitalier de Recherche Clinique (12.07, 2011) and by funding from \u00c9tablissement Fran\u00e7ais du Sang and Sanquin Blood Supply.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta21620","type":"journal-article","created":{"date-parts":[[2017,10,25]],"date-time":"2017-10-25T09:42:48Z","timestamp":1508924568000},"page":"1-118","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":23,"title":["The Age of BLood Evaluation (ABLE) randomised controlled trial: description of the UK-funded arm of the international trial, the UK cost\u2013utility analysis and secondary analyses exploring factors associated with health-related quality of life and health-care costs during the 12-month 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