ABLE
ABLE: Age of Transfused Blood in Critically Ill Adults
Lacroix et al. Canadian Critical Care Trials Group. NEJM 2015; 372:1410-1418. doi:10.1056/NEJMoa1500704
Clinical Question
- In critically ill patients requiring blood, does transfusion with “fresh” RBC’s (stored for 8 days or less) compared with standard issue RBCs (stored 2-42 days) reduce 90 day mortality?
Design
- Multicenter, randomised controlled trial
- Randomisation occurred by a centralised computer with stratification according to study site
- Patients were assigned in a 1:1 ratio to one of the two study groups with the use of permuted blocks of varying sizes of 6, 8 or 10
- Intention to treat analysis
- Interim analyses occurred after each consecutive group of 500 patients had been followed for 90 days
- Estimated that 2266 patients was required for the study to be 90% powered to detect an absolute difference in mortality of 5% from a baseline mortality of 25%
Setting
- 64 tertiary care intensive care units in Canada and Europe
- 26 Canada, 20 UK, 10 France, 7 Netherlands, 1 Belgium
- March 2009 – May 2014
Population
- Inclusion:
- Patients administered RBC transfusion up to seven days post ICU-admission
- Anticipated length of mechanical ventilation of at least 48 hours
- Exclusion: < 18 years; RBC transfusion prior to ICU admission; terminal illness with life expectancy < 3 months; undergone elective cardiac surgical care during the same hospitalisation; futility; refusal to receive transfusion; intensivist refused participation in study; no available RBCs in the blood bank with a storage time of 7 days or less; requirement of more than one unit of uncross-matched blood; patients requiring specifically matched blood due to autoantibodies
- 2510 patients randomised of whom outcome data available for 2430
- baseline characteristics were similar in both groups
- mean APACHE 21.8
- mean length of ICU stay 2.4 days
- mostly medical (71%) and emergency patients (96.7%)
- most required invasive ventilation (97.4%) and vasoactive support (62.8%)
- mean pretransfusion Hb was 7.7g/dl
Intervention
- ‘Fresh’ blood transfusion – stored for 8 days or less
- 1211 patients
- protocol specified that if red cells < 8 days old were not available then the freshest compatible red cells were issued. The average duration of storage was 6.1 +/- 4.9 days
- 84% received only RBCs stored for <8 days
Control
- Standard blood transfusion – stored 2 – 42 days
- 1219 patients
- the oldest compatible red cells were issued. The average duration of storage was 22.0 +/- 8.4 days
For both intervention and control groups:
- All blood was leukoreduced before storage and suspended in saline-adenine-glucose-mannitol (SAGM)
- Local guidelines and practice for bedside transfusion were adopted
- All decisions regarding patient care was at the discretion of the attending physicians and the clinical team
Outcome
- Primary outcome: 90 day mortality
- 448 patients (37%) vs. 430 patients (35%) (Absolute Risk Difference 1.7%; 95% CI -2.1-5.5)
- Secondary outcomes: No statistical difference between the groups in any of the outcomes
- time to death in ICU, in hospital and by day 28
- major illness including MODS, ARDS, heart failure, cardiac ischaemia or MI, DVT or PE
- duration of respiratory support
- duration of haemodynamic suppport
- duration of renal support
- length of stay in the hospital
- transfusion reactions
- Subgroup analysis: No difference
- 90d mortality in the patients who received a transfusion (excluded 94 patients who did not actually receive blood
- 90d mortality in the patients who only received blood that had been stored for < 8 days vs those that had received blood stored for more than 7 days
Authors’ Conclusions
- Transfusion of fresh red cells, as compared with standard-issue red cells, did not decrease the 90-day mortality among critically ill patients
Strengths
- Concealment of the age of the red cells by an opaque sticker affixed over the expiration and collection dates
- Blood transfusion technologists refrained from releasing information on storage duration to all clinical and research personnel
- Protocol, including details of trial conduct and the statistical analysis plan was published a priori
- Only 3.9% of patients lost to follow up. This was less than the number anticipated when the study was planned
- The rate of adherence to the transfusion protocol was 95.4%
Weaknesses
- 94 patients (3.9%) did not receive any blood transfusion. This has been considered in the sub-group analysis
- Lack of uniform guideline or protocol across centres for transfusion. However, a pragmatic study and this is acknowledged in the manuscript
The Bottom Line
- This study shows that fresh blood which has been stored for < 8 days is no better than blood stored up to 42 days. Transfusion triggers and processes for safe administration of blood are probably more important
External Links
- [article abstract] Age of Transfused Blood in Critically Ill Adults
- [further reading] Transfusion Literature Summaries
- [further reading] Effects of Red-Cell Storage Duration on Patients Undergoing Cardiac Surgery
- further reading] Is fresher blood better? Results from the ABLE study. ESICM News
Metadata
Summary author: @stevemathieu75
Summary date: 15th July 2015
Peer-review editor: @davidslessor
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