Primary and secondary outcomes
| Outcomes | Total (n=171) | TXA (n=89) | Placebo (n=82) | OR (95% CI) | P value |
| Primary outcome | |||||
| Haematoma expansion at 24 hours*, n (%) | 70 (40.9) | 36 (40.4) | 34 (41.5) | 0.96 (0.52 to 1.77) | 0.89 |
| Secondary outcomes | |||||
| mRS at 90 days‡, n (%) | 0.78 | ||||
| 0 | 7 (4.2) | 5 (5.8) | 2 (2.5) | ||
| 1 | 47 (28.3) | 21 (24.4) | 26 (32.5) | ||
| 2 | 27 (16.3) | 15 (17.4) | 12 (15.0) | ||
| 3 | 27 (16.3) | 13 (15.1) | 14 (17.5) | ||
| 4 | 35 (21.1) | 20 (23.3) | 15 (18.8) | ||
| 5 | 8 (4.8) | 5 (5.8) | 3 (3.8) | ||
| 6 | 15 (9.0) | 7 (8.1) | 8 (10.0) | ||
| mRS 4–6 at 90 days‡, n (%) | 58 (34.9) | 32 (37.2) | 26 (32.5) | 1.23 (0.65 to 2.33) | 0.53 |
| Death at 90 days‡, n (%) | 15 (9.0) | 7 (8.1) | 8 (10.0) | 0.82 (0.28 to 2.37) | 0.71 |
| Imaging at 24 hours* | |||||
| ICH growth volume, mean±SD, mL | 7.1±16.0 | 6.6±16.5 | 7.6±15.6 | 0.70 | |
| ICH growth volume >6 mL, n (%) | 54 (31.6) | 26 (29.2) | 28 (34.1) | 0.80 (0.42 to 1.52) | 0.49 |
| ICH growth rate >33%, n (%) | 48 (28.1) | 23 (25.8) | 25 (30.5) | 0.80 (0.41 to 1.55) | 0.50 |
| Midline shift, mean±SD, mm | 2.6±3.7 | 2.8±4.0 | 2.4±3.5 | 0.50 | |
| Median NIHSS score*, Median (IQR) | |||||
| At 24 hours | 10.5 (5.0–15.0) | 11.0 (6.0–14.0) | 10.0 (5.0–16.0) | 0.94 | |
| At discharge | 8.0 (3.0–11.0) | 8.0 (3.0–11.0) | 8.0 (3.0–11.0) | 0.40 | |
| Major thromboembolic events (ACI) at 90 days†, n (%) | 2 (1.2) | 1 (1.2) | 1 (1.3) | 0.96 |
*modified intention-to-treat analysis for 171 patients at 24 hours. Haematoma expansion defined as an increase of >6 mL or a growth of >33%.
†A total of 166 patients were analysed at 90 days (five lost to follow-up).
ACI, acute cerebral infarction; ICH, intracranial haemorrhage; mRS, modified Rankin Scale; TXA, tranexamic acid.