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

Completed

Conditions: Critically ill patients requiring red cell transfusions and having a probability of 28-day all-cause mortality exceeding 25%
Signs and Symptoms
Transfusions

Registration Number: ISRCTN44878718

Lead Sponsor: Sainte-Justine Hospital Research Centre (Centre de recherche du CHU Sainte-Justine) (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 2510

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
90-day all cause mortality.

Secondary Outcome Measures

Name	Time	Method
1. Other mortality rates and survival times as measured at ICU discharge, hospital discharge, 28 days and 6 months post-discharge<br>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<br>3. Serious nosocomial infections including:<br>3.1. Nosocomial pneumonia<br>3.2. Deep tissue infections (e.g. peritonitis, mediastinitis)<br>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<br>4. Adverse events and transfusion reactions as measured while in ICU<br>5. Length of stay (ICU and hospital)<br>6. Length of time requiring respiratory, haemodynamic and renal support as measured while in IC