Table 1:
Baseline Clinical and Demographic Characteristics
| Total n = 291 | DFO (n= 146) | PLACEBO (n=145) | |
|---|---|---|---|
| Age (years) | 59 (51 - 70) | 62 (54 - 70) | |
| Female | 57 (39.0%) | 55 (37.9%) | |
| Race | |||
| White | 83 (56.8%) | 98 (67.6%) | |
| Black | 31 (21.2%) | 33 (22.8%) | |
| Asian | 25 (17.1%) | 12 (8.3%) | |
| Native American or Alaskan | 2 (1.4%) | 0 (0%) | |
| Native Hawaiian/Pacific Islander | 3 (2.1%) | 1 (0.7%) | |
| Unknown/Multiple | 2 (1.4%) | 1 (0.7%) | |
| Hispanic or Latino | 22 (15.1%) | 26 (17.9%) | |
| Glasgow Coma Scale Score) 1 | 14 (12 - 15) | 14 (12 - 15) | |
| NIHSS 2 | 13 (8 - 16) | 13 (8.5 - 19) | |
| Intracerebral hemorrhage score <=2 | 140 (95.9%) | 137 (94.5%) | |
| Medical History | |||
| Hypertension | 113 (77.4%) | 124 (85.5%) | |
| Diabetes mellitus | 32 (21.9%) | 43 (29.7%) | |
| Cardiac disease | 15 (10.3%) | 14 (9.7%) | |
| Pulmonary disease | 30 (20.5%) | 27 (18.6%) | |
| Previous ischemic stroke or TIA | 10 (6.8%) | 16 (11.0%) | |
| Previous ICH | 7 (4.8%) | 3 (2.1%) | |
| Previous drug use | |||
| Antiplatelet agents | 42 (28.8%) | 49 (33.8%) | |
| Warfarin | 1 (0.7%) | 1 (0.7%) | |
| Antihypertensives | 120 (82.2%) | 124 (85.5%) | |
| Statins | 38 (26.0%) | 36 (24.8%) | |
| Modified Rankin Scale score before ICH | |||
| Score of 0 | 132 (90.4%) | 128 (88.3%) | |
| Score of 1 | 14 (9.6%) | 17 (11.7%) | |
| Blood glucose (mg/dL) | 133.5 (114 - 155) | 138 (118 - 164) | |
| Blood pressure (mmHg) | |||
| Systolic | 135 (125 - 148) | 138 (125 - 148) | |
| Diastolic | 71 (63 - 80) | 70 (59 - 80) | |
| Time from ICH to treatment (hrs) | |||
| Median (IQR) | 17.6 (10.8 - 22.5) | 19.5 (11.2 - 22.8) | |
| ≤12 | 44 (30.1%) | 46 (31.7%) | |
| >12 | 102 (69.9%) | 99 (68.3%) | |
| ICH location | |||
| Lobar | 26 (17.8%) | 33 (22.8%) | |
| Deep (thalamic) | 46 (31.5%) | 60 (41.4%) | |
| Deep (non-thalamic) | 74 (50.7%) | 52 (35.9%) | |
| ICH volume (mL) | 12.4 (6.1 – 24.7) | 13.0 (6.7 – 26.7) | |
| Intraventricular hemorrhage 3 | |||
| n | 52 (35.6%) | 68 (46.9%) | |
| Volume (mL) | 3.7 (9.8) | 4.7 (10.0) | |
1
6 subjects missing GCS (3 DFO, 3 Placebo)
2
2 subjects missing NIHSS (1 DFO, 1 Placebo)
3
Based on volumetric measurements by a central reader
Data are median (IQR), n (%), or mean (SD).
In accordance with the CONSORT guidelines on the reporting of randomized clinical trials, statistical tests of baseline characteristics were not conducted; instead, the clinical relevance of the observed imbalances is considered [13]. Table 1 presents baseline characteristics by treatment received,which differs from randomized treatment for 4 subjects.