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| [ ...Back to search results ] | [ Print-friendly version ] |
| Age of BLood Evaluation (ABLE) trial in the resuscitation of critically ill patients |
| ISRCTN | ISRCTN44878718 |
| DOI | 10.1186/ISRCTN44878718 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Age of BLood Evaluation (ABLE) trial in the resuscitation of critically ill patients |
| Scientific title | Age of BLood Evaluation (ABLE) trial in the resuscitation of critically ill patients: a multicentre randomised controlled superiority clinical trial |
| Acronym | ABLE |
| Serial number at source | MCT-90648 |
| 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. |
| Lay summary | |
| Ethics approval | Ethics approval received from the Research Ethics Committee of Hôpital Sainte-Justine (Montréal) on the 18th July 2008 (ref: 2746). |
| Study design | Double blind (participant, investigator, caregiver, outcome assessor, data analyst), randomised parallel trial |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Critically ill patients requiring red cell transfusions and having a probability of 28-day all-cause mortality exceeding 25% |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/12/2008 |
| Anticipated end date | 01/04/2013 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 2510 |
| Interventions |
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). |
| Primary outcome measure(s) | 90-day all cause mortality. |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-90648) |
| Trial website | |
| Publications | |
| Contact name | Dr Jacques Lacroix |
| Address |
Hôpital Sainte-Justine
3175 Cöte Sainte-Catherine |
| City/town | Montreal, Quebec |
| Zip/Postcode | H3T 1C5 |
| Country | Canada |
| Tel | +1 514 345 4931 ext. 5556 |
| Fax | +1 514 345 7731 |
| jacques_lacroix@ssss.gouv.qc.ca | |
| Sponsor | Sainte-Justine Hospital Research Centre (Centre de recherche du CHU Sainte-Justine) (Canada) |
| Address | 3175 Côte Sainte-Catherine |
| City/town | Montreal, Quebec |
| Zip/Postcode | H3T 1C5 |
| Country | Canada |
| Sponsor website: | http://www.recherche-sainte-justine.qc.ca |
| Date applied | 22/08/2008 |
| Last edited | 04/09/2008 |
| Date ISRCTN assigned | 22/08/2008 |
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