Baseline characteristics of the participants
Characteristics | Total (n=171) | TXA (n=89) | Placebo (n=82) | P value |
Age, mean±SD, year | 55.9±11.6 | 56.7±12.2 | 55.0±10.8 | 0.36 |
Male, n (%) | 124 (72.5) | 63 (70.8) | 61 (74.4) | 0.60 |
NIHSS, median (IQR) | 11.0 (7.0–15.0) | 11.0 (7.0–15.0) | 10.0 (6.0–15.0) | 0.54 |
GCS, median (IQR) | 14.0 (11.0–15.0) | 14.0 (11.0–15.0) | 14.0 (11.0–15.0) | 0.64 |
History, n (%) | ||||
Stroke/TIA | 8 (4.7) | 5 (5.6) | 3 (3.7) | 0.54 |
CHD/MI | 3 (1.8) | 1 (1.1) | 2 (2.4) | 0.51 |
Hypertension | 114 (66.7) | 64 (71.9) | 50 (61.0) | 0.13 |
Diabetes | 18 (10.5) | 12 (13.5) | 6 (7.3) | 0.26 |
Smoking | 45 (26.3) | 21 (23.6) | 24 (29.3) | 0.40 |
Alcohol | 56 (32.7) | 30 (33.7) | 26 (31.7) | 0.78 |
Previous antiplatelet therapy, n (%) | 5 (2.9) | 4 (4.5) | 1 (1.2) | 0.39 |
Previous antihypertensive therapy, n (%) | 43 (25.1) | 24 (27.0) | 19 (23.2) | 0.19 |
Admission SBP, mean±SD, mm Hg | 173.7±27.7 | 176.2±27.5 | 171.1±27.9 | 0.23 |
Admission DBP, mean±SD, mm Hg | 101.2±18.5 | 99.7±16.5 | 102.9±20.4 | 0.27 |
Admission lab test, mean±SD | ||||
Glucose, mmol/L | 7.8±2.8 | 8.2±3.0 | 7.4±2.6 | 0.10 |
WCC, 109/L | 9.7±4.9 | 9.8±5.8 | 9.6±3.9 | 0.77 |
PLT, 109/L | 226.8±106.6 | 243.2±137.7 | 209.2±52.4 | 0.04 |
INR | 1.0±0.1 | 1.0±0.1 | 1.0±0.1 | 0.29 |
Fbg, g/L | 2.7±1.4 | 2.8±1.6 | 2.7±1.0 | 0.79 |
APTT, s | 29.2±6.4 | 28.7±5.9 | 29.7±7.0 | 0.35 |
PT, s | 11.8±2.9 | 11.7±2.7 | 12.0±3.1 | 0.42 |
ICH Volume, Mean±SD, mL | 23.7±18.7 | 25.3±19.7 | 22.0±17.5 | 0.25 |
Midline shift, Mean±SD, mm | 2.5±3.7 | 2.6±4.0 | 2.3±3.4 | 0.60 |
ICH Location, n (%) | ||||
Supratentorial lobar | 44 (25.7) | 22 (24.7) | 22 (26.8) | 0.75 |
Supratentorial deep | 127 (74.3) | 67 (75.3) | 60 (73.2) | 0.75 |
Thalamus | 16/127 (12.6) | 13/67 (19.4) | 3/60 (5.0) | 0.01 |
Basal ganglia | 111/127 (87.4) | 54/67 (80.6) | 57/60 (95.0) | 0.01 |
Intraventricular tricular haemorrhage, n (%) | 33 (19.3) | 18 (20.2) | 15 (18.3) | 0.75 |
Spot sign*, n (%) | 94 (55.0) | 50 (56.2) | 44 (53.7) | 0.49 |
Black Hole sign†, n (%) | 47 (27.5) | 25 (28.1) | 22 (26.8) | 0.85 |
Blend sign‡, n (%) | 107 (62.6) | 56 (62.9) | 51 (62.2) | 0.62 |
ICH aetiology, n (%) | 0.31 | |||
Hypertension | 166 (97.1) | 88 (98.9) | 78 (95.1) | |
CAA | 1 (0.6) | 1 (1.2) | ||
Others | 4 (2.3) | 1 (1.1) | 3 (3.7) |
P value for comparison between patients with TXA and placebo.
*Ninety-four of 171 patients were enrolled in this trial via three subcentres using the spot sign on CTA as the entry criterion.
†Seventy-seven of 171 patients were enrolled in this trial via seven subcentres using black hole sign and blend sign on NCCT as the entry criterion. Twenty-four of 77 patients in seven subcentres (NCCT screening) were positive for black hole sign (+), 23 of 94 patients in three subcentres (CTA screening) were positive for black hole sign (+).
‡Fifty-six of 77 patients in seven subcentres (NCCT screening) were positive for blend sign (+), 51 of 94 patients in three subcentres (CTA screening) were positive for blend sign (+).
APTT, activated partial thromboplastin time; CAA, cerebral amyloid angiopathy; CHD, coronary heart disease; CTA, CT angiography; DBP, diabolic blood pressure; Fbg, fibrinogen; GCS, Glasgow Coma Scale; ICH, intracerebral haemorrhage; INR, international normalised ratio; MI, myocardial infarction; mRS, modified Rankin Scale; NCCT, non-contrast CT; NIHSS, National Institutes of Health Stroke Scale; PLT, platelet; PT, prothrombin time; SBP, systolic blood pressure; TIA, transient ischaemic attack; TXA, tranexamic acid; WCC, white cell count.