Condition category
Signs and Symptoms
Date applied
22/08/2008
Date assigned
22/08/2008
Last edited
15/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.recherche-sainte-justine.qc.ca

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

Funding Body Type

government organisation

Funding Body Subtype

Federal/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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25853745

Publication citations

Additional files

Editorial Notes