Outcomes by randomised treatment group (tranexamic acid vs placebo) split by prerandomisation baseline SBP
| SBP≤170 mm Hg | Tranexamic acid | Placebo | cOR/OR/HR/MD (95% CI) | P value |
| N (%) | 590 | 562 | ||
| Haematoma | ||||
| Change in volume from baseline to 24 hours,* mL | 3.3 (15.9) | 5.1 (15.8) | −1.99 (−3.90, to 0.08) | 0.041 |
| Haematoma expansion (%) | 132 (24.3) | 161 (32.5) | 0.62 (0.47, 0.82) | 0.001 |
| Haematoma expansion >33% (%) | 101 (18.6) | 119 (24) | 0.69 (0.51, 0.94) | 0.019 |
| Day 2 | ||||
| Death (%) | 15 (2.5) | 33 (5.9) | 0.35 (0.18, 0.68) | 0.002 |
| SAEs (%) | 175 (29.7) | 215 (38.3) | 0.62 (0.48, 0.81) | <0.001 |
| Day 7 | ||||
| NIHSS | 9.8 (7.9) | 10.6 (8.9) | −1.21 (−1.92, to 0.51) | 0.001 |
| Death (%) | 43 (7.3) | 64 (11.4) | 0.53 (0.34, 0.83) | 0.006 |
| SAEs (%) | 217 (36.8) | 247 (44) | 0.67 (0.52, 0.87) | 0.003 |
| Day 90 | ||||
| Primary outcome | ||||
| mRS [/6] | 4 [2,5] | 4 [2,5] | 0.73 (0.59, 0.91) | 0.005 |
| Sensitivity analysis | ||||
| mRS, unadjusted | 4 [2,5] | 4 [2,5] | 0.85 (0.69, 1.04) | 0.13 |
| mRS, adjusted for HV | 4 [2,5] | 4 [2,5] | 0.78 (0.63, 0.97) | 0.025 |
| mRS, adjusted for HV and location~ | 4 [2,5] | 4 [2,5] | 0.76 (0.61, 0.94) | 0.012 |
| mRS>3 (%) | 414 (70.2) | 418 (74.4) | 0.66 (0.48, 0.90) | 0.010 |
| Death (%) | 116 (19.7) | 130 (23.1) | 0.74 (0.58, 0.95) | 0.020 |
| SAEs (%) | 258 (43.7) | 279 (49.6) | 0.72 (0.55, 0.93) | 0.012 |
| EQ-5D HUS (/1) | 0.35 (0.4) | 0.32 (0.4) | 0.04 (0.0, 0.08) | 0.046 |
| EQ-VAS (/100) | 49.5 (33.2) | 46.7 (33.1) | 3.53 (0.20, 6.86) | 0.038 |
| Discharge | ||||
| Length of hospital stay, days | 63.7 (46.7) | 63.8 (47.7) | 2.08 (−3.30, 7.46) | 0.45 |
| Death by discharge (%) | 87 (14.7) | 107 (19) | 0.67 (0.47, 0.96) | 0.030 |
| SBP>170 mm Hg | ||||
| N (%) | 571 | 602 | ||
| Haematoma | ||||
| Change in volume from baseline to 24 hours,* mL | 4.2 (15.8) | 4.7 (16.1) | −0.89 (−2.78, 1.00) | 0.36 |
| Haematoma expansion (%) | 133 (26.1) | 143 (25.4) | 1.02 (0.77, 1.35) | 0.90 |
| Haematoma expansion >33% (%) | 101 (19.8) | 125 (22.2) | 0.84 (0.63, 1.14) | 0.27 |
| Day 2 | ||||
| Death (%) | 25 (4.4) | 24 (4) | 1.01 (0.55, 1.84) | 0.99 |
| SAEs (%) | 204 (35.7) | 202 (33.6) | 1.05 (0.81, 1.36) | 0.71 |
| Day 7 | ||||
| NIHSS | 10.5 (8.7) | 10 (8.4) | 0.32 (−0.43, 1.08) | 0.40 |
| Death (%) | 58 (10.2) | 59 (9.8) | 0.94 (0.62, 1.42) | 0.76 |
| SAEs (%) | 239 (41.9) | 250 (41.5) | 0.95 (0.73, 1.22) | 0.67 |
| Day 90 | ||||
| Primary outcome | ||||
| mRS at day 90 [/6] | 4 [2,5] | 4 [2,5] | 1.05 (0.85, 1.30) | 0.63 |
| Sensitivity analysis | ||||
| mRS at day 90, unadjusted | 4 [2,5] | 4 [2,5] | 1.15 (0.94, 1.41) | 0.16 |
| mRS, adjusted for baseline HV | 4 [2,5] | 4 [2,5] | 0.99 (0.79, 1.22) | 0.90 |
| mRS, adjusted for baseline HV and location | 4 [2,5] | 4 [2,5] | 1.00 (0.80, 1.24) | 0.99 |
| mRS>3 (%) | 409 (71.6) | 414 (68.8) | 1.09 (0.79, 1.51) | 0.59 |
| Death (%) | 134 (23.5) | 119 (19.8) | 1.13 (0.88, 1.44) | 0.35 |
| SAEs (%) | 263 (46.1) | 277 (46) | 0.92 (0.71, 1.18) | 0.50 |
| EQ-5D HUS (/1) | 0.34 (0.39) | 0.37 (0.4) | −0.01 (−0.05, 0.03) | 0.65 |
| EQ-VAS (/100) | 48.1 (34.5) | 49.9 (33.1) | 0.53 (−2.63, 3.69) | 0.74 |
| Discharge | ||||
| Length of hospital stay, days | 62.3 (47.6) | 63.2 (48.5) | 1.72 (−3.81, 7.24) | 0.54 |
| Death by discharge (%) | 103 (18) | 98 (16.3) | 1.02 (0.72, 1.44) | 0.93 |
Treatment effect of tranexamic acid versus placebo assessed using Cox proportional hazards, multiple linear, binary or ordinal logistic regression with adjustment for baseline prognostic factors.
Bold p-values indicate <0.05
*Also adjusted for baseline haematoma volume.
cOR, common OR; EQ-VAS, EuroQoL Visual Analogue Scale; EQ-5D HUS, EuroQoL-5 Dimensions Health Utility Status; HV, haematoma volume; MD, mean difference; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; SAEs, serious adverse events; SBP, systolic blood pressure.