Table 3.
Complications and adverse events
| Packed red blood cells and lyophilised plasma group (n=142) | Sodium chloride group (n=130) | |||
|---|---|---|---|---|
| Any Organ Failure by system during hospital stay up to day 30 [SOFA ≥3] | ||||
| Respiratory | ||||
| Yes | 83 (58%) | 68 (52%) | ||
| No | 35 (25%) | 45 (35%) | ||
| Missing | 24 (17%) | 17 (13%) | ||
| Neurological | ||||
| Yes | 89 (63%) | 74 (57%) | ||
| No | 50 (35%) | 56 (43%) | ||
| Missing | 3 (2%) | 0 | ||
| Cardiovascular | ||||
| Yes | 95 (67%) | 80 (62%) | ||
| No | 43 (30%) | 46 (35%) | ||
| Missing | 4 (3%) | 4 (3%) | ||
| Liver | ||||
| Yes | 13 (9%) | 6 (5%) | ||
| No | 117 (82%) | 116 (89%) | ||
| Missing | 12 (9%) | 8 (6%) | ||
| Coagulation | ||||
| Yes | 12 (8%) | 19 (15%) | ||
| No | 123 (87%) | 108 (83%) | ||
| Missing | 7 (5%) | 3 (2%) | ||
| Renal | ||||
| Yes | 32 (23%) | 33 (25%) | ||
| No | 104 (73%) | 93 (72%) | ||
| Missing | 6 (4%) | 4 (3%) | ||
| Multi-organfailure | ||||
| Yes | 86 (61%) | 78 (60%) | ||
| No | 56 (39%) | 52 (40%) | ||
| Missing | 0 | 0 | ||
| Acute respiratory distress syndrome | ||||
| Yes | 9 (6%) | 3 (2%) | ||
| No | 133 (94%) | 126 (97%) | ||
| Missing | 0 | 1 (1%) | ||
| Suspicion or clinical evidence of infection | ||||
| Yes | 92 (65%) | 83 (64%) | ||
| No | 50 (35%) | 47 (36%) | ||
| Missing | 0 (0%) | 0 | ||
| Type of Infection* | ||||
| Intra-abdominal | 262 (18%) | 15 (12%) | ||
| Meningitis | 3 (2%) | 1 (1%) | ||
| Respiratory | 61 (43%) | 59 (45%) | ||
| UTI | 5 (4%) | 10 (8%) | ||
| Soft tissue | 35 (25%) | 20 (15%) | ||
| Indwelling device | 16 (11%) | 13 (10%) | ||
| Blood-born | 8 (6%) | 7 (5%) | ||
| Other | 46 (32%) | 40 (31%) | ||
| Thromboembolism | ||||
| Yes | 17 (12%) | 11 (8%) | ||
| No | 125 (88%) | 118 (91%) | ||
| Missing | 0 | 1 (1%) | ||
| Type of Thromboembolism* | ||||
| Deep Vein Thrombosis | 3 (2%) | 3 (2%) | ||
| Pulmonary embolism | 9 (6%) | 8 (6%) | ||
| Stroke | 3 (2%) | 0 | ||
| Other | 2 (1%) | 3 (2%) | ||
| Transfusion-related acute lung injury | ||||
| Yes | 0 | 1 (1%) | ||
| No | 142 (100%) | 128 (99%) | ||
| Missing | 0 | 1 (1%) | ||
| Transfusion-related complications (in first 24 hours in emergency department) | ||||
| Yes | 11 (7%) | 9 (7%) | ||
| No | 137 (93%) | 128 (93%) | ||
| Missing | 0 | 0 | ||
Data are n (%). This list of adverse events and complications are for the 272 participants that completed at least one daily assessment form. PRBC=packed red blood cells. SOFA=sequential organ failure assessment. UTI=urinary tract infection.
*
Multiple responses are possible for the type of thromboembolism and type of infection.