Table 2. Secondary Trial Outcomes by Treatment Groupa.
| Outcome | Tranexamic Acid (n = 447) | Placebo (n = 453) | Difference, % (95% CI) | P value | |
|---|---|---|---|---|---|
| Observedb | Adjustedc | ||||
| 24-h Mortality | 16 (3.6) | 17 (3.7) | 0.15 (−2.3 to 2.6) | .90 | .98 |
| In-hospital mortality | 37 (8.6) | 43 (9.7) | 1.1 (−2.7 to 4.9) | .58 | .94 |
| 6-h Outcomes | |||||
| Laboratory values, median (IQR) | |||||
| Total blood component transfusion, U | 0 (0 to 2) | 0 (0 to 2) | NA | .75 | .97 |
| PRBC transfusion, U | 0 (0 to 1) | 0 (0 to 1) | NA | .54 | .94 |
| Plasma transfusion, U | 0 (0 to 0) | 0 (0 to 0) | NA | .16 | .78 |
| Platelet transfusion, U | 0 (0 to 1) | 0 (0 to 1) | NA | .54 | .94 |
| Crystalloid infusion volume, mL | 1600 (600 to 3300) | 1600 (600 to 3200) | NA | .94 | .98 |
| 24-h Outcomes | |||||
| Laboratory values, median (IQR) | |||||
| Total blood component transfusion, U | 0 (0 to 2) | 0 (0 to 2) | NA | .69 | .97 |
| PRBC transfusion, U | 0 (0 to 1) | 0 (0 to 1) | NA | .47 | .94 |
| Plasma transfusion | 0 (0 to 0) | 0 (0 to 0) | NA | .11 | .78 |
| Platelet transfusion | 0 (0 to 0) | 0 (0 to 0) | NA | .98 | .98 |
| Crystalloid infusion volume, mL | 3100 (1235 to 5600) | 2750 (1282.5 to 5525) | NA | .39 | .94 |
| Lactate, median (IQR), mmol/Ld | 2.9 (1.9 to 3.9) | 2.6 (1.8 to 4.2) | NA | .74 | .97 |
| Initial presenting international normalized ratioe | |||||
| Median (IQR) | 1.1 (1 to 1.2) | 1.1 (1 to 1.2) | NA | .95 | .98 |
| >1.4 | 43 (9.6) | 49 (10.7) | 1.1 (−2.8 to 5.1) | .58 | .94 |
| Initial presenting rapid thromboelastography measurements, median (IQR) | |||||
| Activated clotting time, sf | 113 (105 to 121) | 113 (105 to 128) | NA | .48 | .94 |
| K-time, ming | 1.5 (1.2 to 2) | 1.5 (1.1 to 2) | NA | .29 | .94 |
| α-Angleh | 72.4 (68.4 to 75.7) | 73.35 (68.2 to 76.5) | NA | .19 | .78 |
| Maximal amplitudei | 61.7 (57 to 66.1) | 62.8 (57 to 67.5) | NA | .07 | .75 |
| LY30, %j | 5.45 (1.7 to 50) | 4.35 (1.7 to 50) | NA | .80 | .97 |
| Hyperfibrinolysisj | 145 (32.4) | 144 (31.6) | −0.9 (−7.0 to 5.2) | .78 | .97 |
| Multiple organ failure | 33 (7.4) | 39 (8.6) | 1.2 (−2.4 to 4.7) | .52 | .94 |
| Acute respiratory distress syndrome | 42 (9.4) | 39 (8.6) | −0.8 (−4.6 to 2.9) | .66 | .97 |
| Nosocomial infection | 88 (19.7) | 66 (14.5) | −5.2 (−10.1 to −0.3) | .04 | .75 |
| Seizure in first 24 h | 5 (1.1) | 7 (1.5) | 0.4 (−1.0 to 1.9) | .58 | .94 |
| Pulmonary embolism | 13 (2.9) | 7 (1.5) | −1.3 (−3.3 to 0.5) | .16 | .78 |
| Deep vein thrombosis | 12 (2.7) | 7 (1.5) | −1.2 (−3.3 to 0.5) | .23 | .83 |
Abbreviations: IQR, interquartile range; LY30, 30-minute fibrinolysis; NA, not applicable; PRBC, packed red blood cells.
Data are presented as number (percentage) of patients unless otherwise indicated. For all transfusion volume outcomes, the 24-hour period began at the time of enrollment or randomization in the prehospital setting. Thromboelastography measurements provide viscoelastic properties of a blood sample. Activated clotting time is the time in seconds between initiation of the test and the initial fibrin formation and is increased with factor deficiency or severe hemodilution. The α-angle is the slope of the tracing that represents the rate of clot formation, decreasing with hypofibrinogenemia or platelet deficiency. K-time is the time in minutes needed to reach 20-mm clot strength and is generally increased with hypofibrinogenemia or platelet deficiency. The maximal amplitude is the greatest amplitude of the tracing and reflects platelet contribution to clot strength. LY30 is the percent amplitude reduction at 30 minutes after the maximal amplitude and when elevated reflects a state of hyperfibrinolysis (estimated percent lysis >7.5%).
Continuous variables were compared with the Wilcoxon rank-sum test. Categorical variables were compared with the Fisher exact test.
Adjusted using Benjamini-Hochberg procedure to account for the false discovery rate with multiple comparisons. False discovery rate correction is a powerful method to ensure the probability of a type I error remains at the prespecified level across all hypotheses tested (35 tests including secondary outcomes and prespecified subgroup interactions).
Unavailable in 140 patients in the tranexamic acid group (n = 307) and 149 patients in the placebo group (n = 304).
Unavailable in 25 patients in the tranexamic acid group and 23 patients in the placebo group (n = 422; n = 433 respectively).
Unavailable in 74 patients in the tranexamic acid group (n = 373) and 58 patients in the placebo group (n = 398).
Unavailable in 45 patients in the tranexamic acid group (n = 402) and 33 patients in the placebo group (n = 423).
Unavailable in 42 patients in the tranexamic acid group (n = 405) and 26 patients in the placebo group (n = 430).
Unavailable in 44 patients in the tranexamic acid group (n = 403) and 29 patients in the placebo group (n = 427).
Unavailable in 153 patients in the tranexamic acid group (n = 294) and 156 patients in the placebo group (n = 300) and defined by an estimated percent lysis greater than 7.5%.