Contact information
Type
Scientific
Primary contact
Dr Jacques Lacroix
ORCID ID
Contact details
Hôpital Sainte-Justine
3175 Cöte Sainte-Catherine
Montreal
H3T 1C5
Canada
+1 (0)514 345 4931 ext. 5556
jacques_lacroix@ssss.gouv.qc.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-90648
Study information
Scientific title
Age of BLood Evaluation (ABLE) trial in the resuscitation of critically ill patients: a multicentre randomised controlled superiority clinical trial
Acronym
ABLE
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.
Ethics approval
Research Ethics Committee of Hôpital Sainte-Justine (Montréal), 18/07/2008, ref: 2746
Study design
Double blind (participant, investigator, caregiver, outcome assessor, data analyst), randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Critically ill patients requiring red cell transfusions and having a probability of 28-day all-cause mortality exceeding 25%
Intervention
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).
Intervention type
Other
Phase
Drug names
Primary outcome measure
90-day all cause mortality
Secondary outcome measures
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
Overall trial start date
01/12/2008
Overall trial end date
01/04/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2510
Participant 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
Recruitment start date
01/12/2008
Recruitment end date
01/04/2013
Locations
Countries of recruitment
Canada
Trial participating centre
Hôpital Sainte-Justine
Montreal
H3T 1C5
Canada
Sponsor information
Organisation
Sainte-Justine Hospital Research Centre (Centre de recherche du CHU Sainte-Justine) (Canada)
Sponsor details
3175 Côte Sainte-Catherine
Montreal
Quebec
H3T 1C5
Canada
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-90648)
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR, IRSC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25853745