Table 2. Characteristics and outcome of patients according to consent type.
| Baseline variable | Self-consent | Proxy consent | P | One-stage | Two-stage | P |
|---|---|---|---|---|---|---|
| Patients randomised | 817 (35.1%) | 1507 (64.8%) | - | 1553 (66.8%) | 771 (33.2%) | - |
| Age (years) | 66.23 (13.39) | 70.34 (13.83) | <0.001 | 68.5 (13.7) | 69.8 (13.9) | 0.027 |
| Sex (male) | 523 (64.0%) | 778 (51.6%) | <0.001 | 902 (58.1%) | 399 (51.8%) | 0.004 |
| Pre-stroke modified Rankin Scale (/5) | 0.0 [0.0, 0.0] | 0.0 [0.0, 1.0] | <0.001 | 0.0 [0.0, 1.0] | 0.0 [0.0, 1.0] | 0.16 |
| Prior antiplatelet therapy | 180 (22.0%) | 431 (28.6%) | 0.001 | 403 (25.9%) | 208 (27.0%) | 0.58 |
| Glasgow coma scale (/15) | 15 [15, 15] | 14 [11, 15] | <0.001 | 15 [12, 15] | 14 [12, 15] | 0.27 |
| NIHSS score [/42] | 7.0 [4.0, 11.0] | 16.0 [10.0, 21.0] | <0.001 | 12.0 [6.0, 18.0] | 14.0 [8.0, 20.0] | <0.001 |
| No aphasia | 706 (86.4%) | 619 (41.1%) | <0.001 | 909 (58.5%) | 416 (54.0%) | 0.036 |
| Aphasia-mild to moderate | 87 (10.6%) | 254 (16.9%) | <0.001 | 227 (14.6%) | 114 (14.8%) | 0.91 |
| Aphasia-severe or mute | 24 (2.9%) | 634 (42.1%) | <0.001 | 417 (26.9%) | 241 (31.3%) | 0.026 |
| Right-sided limb weakness | 273 (33.4%) | 891 (59.1%) | <0.001 | 775 (49.9%) | 389 (50.5%) | 0.80 |
| Systolic blood pressure (mmHg) | 175.6 (30.2) | 174.4 (29.6) | 0.36 | 173.4 (29.2) | 177.6 (30.8) | 0.001 |
| Haematoma volume (mL) | 12.7 (15.7) | 30.2 (30.0) | <0.001 | 21.7 (25.6) | 28.6 (29.6) | <0.001 |
| Intraventricular haemorrhage | 167 (20.7%) | 540 (36.3%) | <0.001 | 445 (29.1%) | 262 (34.2%) | 0.012 |
| Onset-to-CT time (minutes) | 118 [85, 180] | 114 [80, 168] | 0.054 | 116 [83, 171] | 112 [80, 170] | 0.27 |
| UK sites | 655 (80.2%) | 1254 (83.2%) | 0.068 | 1207 (77.7%) | 702 (91.1%) | <0.001 |
| Haematoma expansion | 168 (21.9%) | 402 (30.7%) | <0.001 | 371 (26.6%) | 199 (29.2%) | 0.21 |
| Outcomes -Day 7 | ||||||
| Do not attempt resuscitation | 56 (6.5%) | 453 (30.1%) | <0.001 | 286 (18.5%) | 223 (29.1%) | <0.001 |
| Death | 20 (2.4%) | 204 (13.5%) | <0.001 | 122 (7.9%) | 102 (13.2%) | <0.001 |
| Day 90 | ||||||
| Death | 69 (8.5%) | 430 (28.7%) | <0.001 | 293 (19.0%) | 206 (27.0%) | <0.001 |
| Modified Rankin Scale 4-6 | 247 (30.5%) | 1012 (67.6%) | <0.001 | 792 (51.3%) | 467 (61.3%) | <0.001 |
Data are n (%), mean (standard deviation), or median [interquartile range]. Analyses are Chi-squared test for categorical variables, Mann-Whitney U test for median and t-Student test for mean comparison. NIHSS=National Institutes of Health Stroke Scale. One-stage consent includes one-stage patient and relative consent. Two-stage consents include two-stage patient, relative and doctor consent. Proxy consent includes one- and two-stage relative consent and doctor consent.