Recipient organisationUniversity of EdinburghSource-published name: The University of Edinburgh
Funding£1.3M
PeriodSept 2011 — Jul 2016
In plain English
AI plain-English summary
Every year, thousands of critically ill patients in intensive care receive transfusions of red blood cells that have been stored for weeks—but no one knows if fresher blood would help them survive. The Age of Blood Evaluation Study (ABLE) is a double-blind randomised trial running across 10–12 UK intensive care units, comparing standard-issue red blood cells against cells stored for seven days or less. The trial will enrol 500 UK patients (2,510 total) and track whether receiving fresher blood reduces the 90-day death rate from an expected 25% to 20%. This matters because current transfusion practice assumes storage time is irrelevant, yet older blood undergoes chemical changes that could harm fragile ICU patients. If the trial finds a survival benefit, it would immediately change how blood banks allocate their youngest units—prioritising them for the sickest patients rather than distributing them arbitrarily. If it finds no difference, it would reassure clinicians that current practice is safe, potentially saving the NHS the logistical cost of managing separate fresh-blood inventories. The results will also inform health economic analyses of blood supply chains, a system most people never think about but which quietly underpins modern hospital care.
View original technical description
DESIGN: Double-blind, multicentre, parallel group randomized controlled clinical trial SETTING: 10-12 general adult ICUs. TARGET POPULATION: Adult critically ill patients in ICU who: have had a request for a first Red Blood Cell (RBC) unit transfusion during the first 7 days of ICU admission and have an anticipated requirement for ongoing mechanical ventilation exceeding 48 hours. Exclusions include: age < 16 years; previous enrolment in ABLE; already transfused RBCs during this admission; terminal illness; routine cardiac surgical care; no RBCs available with a storage time of 7 days or difficult cross match; patient objection to RBC transfusion. HEALTH TECHNOLOGY ASSESSED: We will compare: 1) standard issue RBCs with 2) RBCs stored 7 days or less. Post-randomisation group allocation will be maintained for the remainder of the patient’s hospital stay (up to 90 days). The storage age of RBC units will be concealed from clinical and ICU-based research staff and patients using study specific blinding stickers. MEASUREMENT OF COSTS AND OUTCOMES: Primary outcome: 90-days all-cause mortality. Secondary outcomes: 1) mortality rates at hospital and ICU discharge, and at 30-days, 6 and 12 months; 2) differences in organ failures assessed using the multiple organ dysfunction (MODS) scores; 3) differences in nosocomial infections; 4) adverse events including transfusion reactions. We will also measure HRQoL at 6, and 12 months using EuroQol EQ-5D and health resource use with questionnaires. These will be used to conduct a health economic analysis. SAMPLE SIZE: The overall trial is designed to detect an absolute risk reduction of 5% from 25% to 20% (RRR 20%), which requires a total of 2510 patients. We plan a priori defined subgroup analyses of patients with: 1) cardiovascular diseases; 2) multiple trauma; 3) severe sepsis; and 4) acute respiratory distress syndrome. We will recruit 500 patients in the UK.
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