Age of BLood Evaluation (ABLE) trial in the resuscitation of critically ill patients

ISRCTN	ISRCTN44878718
DOI	https://doi.org/10.1186/ISRCTN44878718
Secondary identifying numbers	MCT-90648

Submission date: 22/08/2008
Registration date: 22/08/2008
Last edited: 15/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jacques Lacroix
Scientific

Hôpital Sainte-Justine
3175 Cöte Sainte-Catherine
Montreal
H3T 1C5
Canada

Phone	+1 (0)514 345 4931 ext. 5556
Email	jacques_lacroix@ssss.gouv.qc.ca

Study information

Study design	Double blind (participant, investigator, caregiver, outcome assessor, data analyst), randomised parallel trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Age of BLood Evaluation (ABLE) trial in the resuscitation of critically ill patients: a multicentre randomised controlled superiority clinical trial
Study acronym	ABLE
Study objectives	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(s)	Research Ethics Committee of Hôpital Sainte-Justine (Montréal), 18/07/2008, ref: 2746
Health condition(s) or problem(s) studied	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
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 study start date	01/12/2008
Completion date	01/04/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	2510
Key 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
Key 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
Date of first enrolment	01/12/2008
Date of final enrolment	01/04/2013

Locations

Countries of recruitment

Canada

Study participating centre

Hôpital Sainte-Justine

Montreal
H3T 1C5
Canada

Sponsor information

Sainte-Justine Hospital Research Centre (Centre de recherche du CHU Sainte-Justine) (Canada)
Hospital/treatment centre

3175 Côte Sainte-Catherine
Montreal, Quebec
H3T 1C5
Canada

Website	http://www.recherche-sainte-justine.qc.ca
"ROR"	https://ror.org/01gv74p78

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-90648)
Government organisation / National government

Alternative name(s): Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location: Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/04/2015		Yes	No