Age of BLood Evaluation (ABLE) trial in the resuscitation of critically ill patients
ISRCTN | ISRCTN44878718 |
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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
Scientific
Hôpital Sainte-Justine
3175 Cöte Sainte-Catherine
Montreal
H3T 1C5
Canada
Phone | +1 (0)514 345 4931 ext. 5556 |
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jacques_lacroix@ssss.gouv.qc.ca |
Study information
Study design | Double blind (participant, investigator, caregiver, outcome assessor, data analyst), randomised parallel trial |
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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 |
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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
H3T 1C5
Canada
Sponsor information
Sainte-Justine Hospital Research Centre (Centre de recherche du CHU Sainte-Justine) (Canada)
Hospital/treatment centre
Hospital/treatment centre
3175 Côte Sainte-Catherine
Montreal, Quebec
H3T 1C5
Canada
Website | http://www.recherche-sainte-justine.qc.ca |
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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
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 | |
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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? |
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Results article | results | 09/04/2015 | Yes | No |