Table 4.
Clinical trial secondary outcomes∗
| Outcome | n/N evaluated (%)† red blood cell group |
Relative risk (95% CI) |
Absolute risk difference (95% CI) |
P value | |
|---|---|---|---|---|---|
| Fresh | Standard issue | ||||
| Per-protocol analysis‡ | |||||
| New or progressive MODS§ | 41/85 (48.2) | 38/88 (43.2) | 1.12 (0.81-1.55) | 5.1 (−9.8 to 19.9) | .51 |
| Mortality | |||||
| In ICU | 3/89 (3.4) | 0/89 (0.0) | NA | 3.4 (0.0-7.1) | .08 |
| In hospital | 3/89 (3.4) | 2/89 (2.3) | 1.50 (0.26-8.76) | 1.1 (−3.7 to 6.0) | .65 |
| ≤28 d | 2/89 (2.3) | 2/89 (2.3) | 1.00 (0.14-6.94) | 0.0 (−4.4 to 4.4) | 1.00 |
| ≤90 d | 3/89 (3.4) | 2/89 (2.3) | 1.50 (0.26-8.76) | 1.1 (−3.7 to 6.0) | .65 |
| Morbidity outcomes‖ | |||||
| Sepsis | 9/88 (10.2) | 7/88 (8.0) | 1.28 (0.50-3.30) | 2.3 (−6.2 to 10.8) | .60 |
| Severe sepsis | 0/88 (0.0) | 0/88 (0.0) | NA | ||
| Septic shock | 8/88 (9.1) | 5/88 (5.7) | 1.60 (0.54-4.70) | 3.4 (−4.3 to 11.1) | .39 |
| ARDS¶ | 0/88 (0.0) | 0/88 (0.0) | NA | ||
| Nosocomial infections# | 2/89 (2.3) | 2/89 (2.3) | 1.00 (0.14-6.94) | 0.0 (−4.4 to 4.4) | 1.00 |
MODS, Multiple organ dysfunction syndrome; ICU, intensive care unit; NA, not applicable; ARDS, acute respiratory distress syndrome.
In all comparisons, the fresh red blood cell group was used as the reference. Superiority was checked for the primary outcome and for all secondary outcomes analyzing patients according to their randomization groups. The principal analysis was performed using an unadjusted χ2 comparing the proportion of patients who acquire new or progressive MODS after randomization. The principal measure of effect is an unadjusted absolute risk difference with a 95% CI. Dichotomous secondary outcomes were analyzed using risk differences and 95% CI followed by logistic regression procedures. Continuous outcomes were analyzed using independent t tests or Wilcoxon rank-sum tests depending on distribution of data.
Refers to number of patients with outcome/number of patients evaluated (proportion). n refers to number analyzed when it is less than the group total.
Patients who exclusively received red blood cells 7 days or fewer in the fresh group and all patients in the standard-issue group.
Defined by Proulx and colleagues.17
Sepsis, severe sepsis, and septic shock as defined by Goldstein and colleagues.24