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 designDouble blind (participant, investigator, caregiver, outcome assessor, data analyst), randomised parallel trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAge of BLood Evaluation (ABLE) trial in the resuscitation of critically ill patients: a multicentre randomised controlled superiority clinical trial
Study acronymABLE
Study objectivesThe 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) studiedCritically ill patients requiring red cell transfusions and having a probability of 28-day all-cause mortality exceeding 25%
InterventionExperimental:
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 typeOther
Primary outcome measure90-day all cause mortality
Secondary outcome measures1. 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 date01/12/2008
Completion date01/04/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants2510
Key inclusion criteriaPatients 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 criteriaInvestigators 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 enrolment01/12/2008
Date of final enrolment01/04/2013

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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