Table 2.
1 | Age at ICU entry < 3 days from birth or > 16 years of age |
2 | Post-conception age < 36 weeks on admission to ICU |
3 | Documented RBC transfusion within the 28 days prior to fulfilling the eligibility criteria |
4 | Previously randomized in this study |
5 | Weight < 3.0 kg on ICU admission |
6 | Pregnant |
7 | Conscious objection or unwillingness to receive blood products |
8 | Not expected to survive beyond 24 h, brain death or suspected brain death |
9 | Limitation or withdrawal of care decisions have been made |
10 | Enrollment in another randomized clinical trial which has not been approved for co-enrollment |
11 | Patients for whom autologous and/or directed donation RBCs will be provided |
12 | Patients for whom the treating physician routinely and systematically requests RBC ≤ 14 days of storage |
13 | Patients for whom there systematically exist RBC aliquoting policies that mandate the initial use of units stored for ≤14 days (ex: Pedi-Pack) |
14 | On ECMO or plan to be immediately placed on ECMO at time of enrollment |
15 | Patient predicted or presumed to require a massive transfusion (> 40 ml/kg of all blood components in a 24-h period) according to treating physician judgment |
16 | Refusal by physician |
17 | Inability to obtain consent |
18 | Blood bank personnel experiences difficulties in securing blood products (difficult cross matches, rare blood groups, and diseases like IgA deficiency) |
19 | Insufficient number of ABO type compatible RBC units available in the blood bank at randomization with a storage time ≤ 7 days (minimum 1 unit regardless of patient age) |
20 | All RBC units available for the patient are not leukocyte-reduced prior to storage |
Exclusion criteria # 1 to 17 are ascertained by the research staff with the assistance of the attending ICU team
Exclusion criteria # 18 to 20 are ascertained by blood bank personnel
ECMO extracorporeal membrane oxygenation, ICU intensive care unit, RBC red blood cell