Mortality outcomes
| Variable | Group; n/N (%) | Relative risk (95% CI) | Difference (95% CI) | |
|---|---|---|---|---|
| Fixed-ratio group n = 37 | Control group n = 32 | |||
| All-cause 28-day mortality in ITT analysis* | 13/40 (32.5) | 5/35 (14.3) | 2.27 (0.98 to 9.63) | 18.2 (−0.4 to 36.8) |
| All-cause 28-day mortality per protocol | 11/37 (29.7) | 3/32 (9.4) | 3.17 (1.15 to 18.24)‡ | 20.3 (2.5 to 38.2) |
| Death from exsanguination† | 8/37 (21.6) | 3/32 (9.4) | 2.30 (0.74 to 13.03) | 12.2 (−4.4 to 28.9) |
| Neurologic death (traumatic brain injury/withdrawal of care) | 2/37 (5.4) | 0/32 | NA | 5.4 (−1.8 to 12.7) |
| Death from multiple organ failure | 1/37 (2.7) | 0/32 | NA | 2.7 (−2.5 to 7.9) |
Note: CI = confidence interval, IQR = interquartile range, ITT = intention-to-treat, NA = not applicable.
↵* For the ITT analysis, data were included for 40 patients in the fixed-ratio group and 35 patients in the control group (see Figure 1).
↵† Median time of occurrence after arrival to hospital was 2.8 hours (IQR 1.7–14) in the fixed-ratio group and 4.4 hours (IQR 1.7–14) in the control group.
↵‡ 95% CI generated by bootstrap technique with 10 000 simulations; a continuity correction of 0.5 was used when 0 event was present in the control group in any of the simulations.