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Age of BLood Evaluation (ABLE) trial in the resuscitation of critically ill patients
ISRCTN ISRCTN44878718
ClinicalTrials.gov identifier
Public title Age of BLood Evaluation (ABLE) trial in the resuscitation of critically ill patients
Scientific title Age of BLood Evaluation (ABLE) trial in the resuscitation of critically ill patients: a multicentre randomised controlled superiority clinical trial
Acronym ABLE
Serial number at source MCT-90648
Study hypothesis The transfusion of fresh leuko-reduced red cells (stored for less than 8 days) will lead to a 5% or greater improvement in 90 day all cause mortality and clinically important decreases in morbidity in a vulnerable population of critically ill patients.
Lay summary
Ethics approval Ethics approval received from the Research Ethics Committee of Hôpital Sainte-Justine (Montréal) on the 18th July 2008 (ref: 2746).
Study design Double blind (participant, investigator, caregiver, outcome assessor, data analyst), randomised parallel trial
Countries of recruitment Canada
Disease/condition/study domain Critically ill patients requiring red cell transfusions and having a probability of 28-day all-cause mortality exceeding 25%
Participants - inclusion criteria Patients who:
1. Have had a request for a first red cell unit transfusion in the Intensive Care Unit (ICU), and
2. Have an anticipated length of invasive and/or non-invasive continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BIPAP) mechanical ventilation of at least 48 hours once enrolled, as estimated by the attending physician
Participants - exclusion criteria Investigators and research assistants will exclude patients:
1. Who are less than 16 years of age
2. Who were previously enrolled in the ABLE study
3. Who have already been transfused with red cells during the current hospitalisation
4. Who have an obvious terminal illness documented in the medical record with a life expectancy of less than 3 months
5. Who have undergone routine cardiac surgical care
6. Where a decision to withdraw/withhold some critical care had been made
7. Who are obviously brain dead

Investigators, research assistants and blood bank personnel will also exclude patients:
8. When there are no red cells with a storage time of 7 days or less available in the blood bank that cannot be transported from the blood supplier
9. Who require more than 1 unit of uncross-matched red cells
10. With a known objection to blood transfusions
11. With autologous blood donations
12. Who pose difficulties in securing blood products (rare blood groups), and who are difficult to match
Anticipated start date 01/12/2008
Anticipated end date 01/04/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 2510
Interventions Experimental:
Transfusions of red cells stored less than 8 days issued by the local blood bank. This will be applied up to discharge from the hospital or step-down unit (not more than 90 days post-randomisation).

Control:
Transfusions of standard issue red cells (storage 2 to 42 days).
Primary outcome measure(s) 90-day all cause mortality.
Secondary outcome measure(s) 1. Other mortality rates and survival times as measured at ICU discharge, hospital discharge, 28 days and 6 months post-discharge
2. Number of cases of multiple organ dysfunction syndrome (MODS), highest number of organ failures per patient, MODS score and time to development of MODS as measured while in the ICU
3. Serious nosocomial infections including:
3.1. Nosocomial pneumonia
3.2. Deep tissue infections (e.g. peritonitis, mediastinitis)
3.3. Bacteraemia from organisms not considered normal skin flora and judged important enough to treat by the attending team, as measured while in the ICU
4. Adverse events and transfusion reactions as measured while in ICU
5. Length of stay (ICU and hospital)
6. Length of time requiring respiratory, haemodynamic and renal support as measured while in ICU
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-90648)
Trial website
Publications
Contact name Dr  Jacques  Lacroix
  Address Hôpital Sainte-Justine
3175 Cöte Sainte-Catherine
  City/town Montreal, Quebec
  Zip/Postcode H3T 1C5
  Country Canada
  Tel +1 514 345 4931 ext. 5556
  Fax +1 514 345 7731
  Email jacques_lacroix@ssss.gouv.qc.ca
Sponsor Sainte-Justine Hospital Research Centre (Centre de recherche du CHU Sainte-Justine) (Canada)
  Address 3175 Côte Sainte-Catherine
  City/town Montreal, Quebec
  Zip/Postcode H3T 1C5
  Country Canada
  Sponsor website http://www.recherche-sainte-justine.qc.ca
Date applied 22/08/2008
Last edited 04/09/2008
Date ISRCTN assigned 22/08/2008