Article Figures & Data
- Figure 1
Trial profile. GCS, glasgow coma scale; ICH, intracerebral haemorrhage; TXA, tranexamic acid.
- Figure 2
Post hoc forest plot of primary outcome in subgroups stratified by demographic and clinical characteristics. OR less than 1 favours tranexamic acid over placebo. GCS, Glasgow Coma Scale; NIHSS, National Institutes of Health Stroke Scale; SBP: systolic blood pressure; TXA, tranexamic acid.
- Figure 3
Modified Rankin Scale (mRS) distribution at 90 days. A score of 0 represents no symptoms, 1 represents no disability despite symptoms, 2 represents slight disability but able to look after own affairs, 3 represents moderate disability but able to walk without assistance, 4 represents moderately severe disability (unable to walk or attend to own bodily needs), 5 represents severely disabled (bedridden and requiring constant nursing care) and 6 represents death. GenOR=1.11 (0.65 to 1.90), p=0.70. TXA, tranexamic acid.
- Figure 4
Post hoc forest plot of primary outcome in subgroups stratified by imaging characteristics. OR less than 1 favours tranexamic acid over placebo. ICH, intracerebral haemorrhage; TXA, tranexamic acid.
- Table 1
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.
- Table 2
Time metrics, treatment and complications of the participants
Characteristics Total
(n=171)TXA
(n=89)Placebo
(n=82)P value Time intervals, median (IQR), min Onset to door 120.0 (69.0–190.0) 120.0 (77.0–184.0) 120.0 (66.0–190.0) 0.76 Onset to treatment 290.0 (185.0–370.0) 290.0 (205.0–369.0) 285.0 (180.0–378.0) 0.87 Imaging to treatment 107.5 (73.0–161.0) 128.0 (67.0–172.0) 103.0 (74.0–160.0) 0.40 BP during TXA (Placebo) mean±SD, mm Hg SBPmax 170.3±24.3 170.1±24.8 170.4±23.8 0.95 DBPmax 100.5±16.0 99.5±13.8 101.5±18.0 0.48 MAPmax 123.3±17.7 122.8±16.4 123.9±19.0 0.70 Concomitant therapy during hospitalisation, n (%) Antihypertensive therapy 142 (83.0) 77 (86.5) 65 (79.3) 0.21 Osmotic therapy 125 (73.1) 67 (75.3) 58 (70.7) 0.50 Statin therapy 11 (6.4) 7 (7.9) 4 (4.9) 0.43 Surgical intervention during hospitalisation, n (%) Evacuation of intracranial haematoma 29 (17.0) 16 (18.0) 13 (15.9) 0.71 Decompressive craniectomy 2 (1.2) 1 (1.1) 1 (1.2) 0.95 EVD 3 (1.8) 2 (2.2) 1 (1.2) 0.61 DVT prophylaxis, n (%) Anticoagulation 16 (9.4) 11 (12.4) 5 (6.1) 0.16 Compression 51 (29.8) 31 (34.8) 20 (24.4) 0.14 Complications, n(%) Epilepsy 1 (0.6) 1 (1.2) 0.30 Pulmonary infection 36 (21.1) 20 (22.5) 16 (19.5) 0.64 Gastrointestinal bleeding 17 (9.9) 9 (10.1) 8 (9.8) 0.94 DVT 13 (7.6) 8 (9.0) 5 (6.1) 0.48 P value for comparison between patients with TXA and placebo.
BP, blood pressure; DBP, diastolic blood pressure; DVT, deep venous thrombosis; EVD, external ventricular drain; MAP, mean arterial pressure; SBP, systolic blood pressure; TXA, tranexamic acid.
- Table 3
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.
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