Table 1.
Baseline patient characteristics
| Red blood cell group | Fresh (n = 89) | Standard-issue (n = 89)∗ |
|---|---|---|
| Age (y) | 0.6 (0.3-2.2) | 0.6 (0.4-3.0) |
| ≤28 d | 15 (16.9) | 13 (14.6) |
| 29-365 d | 36 (40.4) | 39 (43.8) |
| >365 d | 38 (42.7) | 36 (40.4) |
| Weight at admission to ICU (kg) | 7.5 (5.4-11.6) | 7.1 (5.0-12.9) |
| Sex | ||
| Girl | 40 (44.9) | 41 (46.1) |
| Boy | 49 (55.1) | 48 (53.9) |
| Time from hospital to ICU admission (d) | 1.6 (0.6-3.9) | 1.6 (0.6-3.6) |
| Recruitment per country | ||
| United States, 2 sites | 1 (1.1) | 2 (2.2) |
| Canada, 2 sites | 88 (98.9) | 87 (97.8) |
| ICU admission to randomization (h) | −6.0 (−8.0 to −5.0) | −6.0 (−8.0 to −5.0) |
| Location of first transfusion | ||
| Operating room | 86 (96.6) | 82 (92.1) |
| ICU | 3 (3.4) | 7 (7.9) |
| Hemoglobin level before first transfusion (g/dL) | 12.8 (11.3-14.2) | 12.5 (10.9-14.5) |
| Location before cardiac surgery | ||
| Home, elective surgery | 58 (65.2) | 64 (71.9) |
| Hospital, pediatrics and cardiology units | 11 (12.4) | 11 (12.4) |
| Neonatal ICU | 14 (15.7) | 10 (11.2) |
| Pediatric ICU | 6 (6.7) | 4 (4.5) |
| No. of organ dysfunctions before surgery (from chart review) | ||
| 0 | 83 (93.3) | 85 (95.5) |
| 1 | 5 (5.6) | 3 (3.4) |
| 2† | 1 (1.1) | 1 (1.1) |
| Univentricular physiology before surgery | 22 (24.7) | 19 (21.3) |
| Cyanotic heart desease before surgery | 46 (51.7) | 46 (51.7) |
| Prior cardiac surgery | 29 (32.6) | 32 (36.0) |
| Genetic abnormality or syndrome | 17 (19.1) | 18 (20.2) |
| Trisomy 21 | 7 (7.9) | 5 (5.6) |
| Di George syndrome | 2 (2.2) | 2 (2.2) |
| Other | 7 (7.9) | 12 (13.5) |
| Unknown | 1 (1.1) | 0 (0.0) |
| Cardiac surgery details | ||
| Emergency procedure | 3 (3.4) | 2 (2.2) |
| STAT mortality category‡ | ||
| 1 | 16 (18.0) | 15 (16.9) |
| 2 | 34 (38.2) | 43 (48.3) |
| 3 | 15 (16.9) | 11 (12.4) |
| 4 | 24 (27.0) | 16 (18.0) |
| 5 | 0 (0.0) | 4 (4.5) |
| Cardiopulmonary bypass duration (min) | ||
| Mean ± SD | 133.3 ± 84.7 | 123.8 ± 63.2 |
| Median (IQR) | 111.5 (85-159.5) | 114 (73-164) |
| Aortic crossclamp time (min) | ||
| Mean ± SD | 70.7 ± 57.8 | 65.0 ± 51.1 |
| Median (IQR) | 67 (27-98) | 54 (28-111) |
| Circulatory arrest, yes | 4 (4.5) | 8 (9.0) |
| Therapeutic hypothermia during surgery | 26 (29.2) | 26 (29.2) |
| If hypothermia: lowest temperature during surgery (°C) | ||
| Mean ± SD | 26.6 ± 3.6 | 26.4 ± 3.9 |
| Median (IQR) | 28 (26-28.7) | 28 (23.5-28.6) |
Values are presented as median (interquartile range [IQR]) or n (%) unless otherwise noted. ICU, Intensive care unit; STAT, Society of Thoracic Surgeons–European Association for Cardio-Thoracic Surgery.
∗
One patient who was randomized to the standard-issue group died in the operating room during cardiac surgery and had no data available for the primary outcome and some secondary outcomes. This patient was not included in the primary outcome but was included in some baseline analyses and in mortality analyses.
†
Multiple organ dysfunction syndrome, as defined by Proulx and colleagues17 and explained further in the Methods section.
‡
Defined by O'Brien and colleagues.23