Table 1:
Baseline and Clinical Characteristics by Treatment and Hematoma Volume.
| Characteristics | Hematoma volume <10 ml | Hematoma volume 10–30 ml | Hematoma volume >30 ml | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| DFO (n=63) | Placebo (n=58) | All | DFO (n=58) | Placebo (n=56) | All | DFO (n=25) | Placebo (n=31) | All | HV by Treatment Interaction p-value | HV p-value from main effect model | |
| Age, years | 58.87±11.26 | 62.07±11.36 | 60.40±11.37 | 58.47±13.35 | 58.27±10.25 | 58.37±11.87 | 65.80±11.56 | 62.58±13.72 | 64.02±12.79 | 0.2161 | 0.0151 |
| Female sex | 26 (41.3) | 24 (41.4) | 50 (41.3) | 22 (37.9) | 19 (33.9) | 41 (36.0) | 9 (36.0) | 12 (38.7) | 21 (37.5) | 0.9001 | 0.6932 |
| Medical history | |||||||||||
| Hyperlipidemia | 27 (42.9) | 31 (53.4) | 58 (47.9) | 15 (25.9) | 19 (33.9) | 34 (29.8) | 11 (44.0) | 8 (25.8) | 19 (33.9) | 0.1530 | 0.0123 |
| Hypertension | 56 (88.9) | 53 (91.4) | 109 (90.1) | 40 (69.0) | 48 (85.7) | 88 (77.2) | 17 (68.0) | 23 (74.2) | 40 (71.4) | 0.5447 | 0.0022 |
| Diabetes mellitus | 17 (27.0) | 19 (32.8) | 36 (29.8) | 8 (13.8) | 19 (33.9) | 27 (23.7) | 7 (28.0) | 5 (16.1) | 12 (21.4) | 0.0583 | 0.3667 |
| Cardiac disease | 10 (15.9) | 7 (12.1) | 17 (14.0) | 2 (3.4) | 6 (10.7) | 8 (7.0) | 3 (12.0) | 1 (3.2) | 4 (7.1) | 0.1116 | 0.1519 |
| Pulmonary disease | 13 (20.6) | 15 (25.9) | 28 (23.1) | 9 (15.5) | 7 (12.5) | 16 (14.0) | 8 (32.0) | 5 (16.1) | 13 (23.2) | 0.2956 | 0.1481 |
| Previous ICH | 4 (6.3) | 0 | 4 (3.3) | 2 (3.4) | 1 (1.8) | 3 (2.6) | 1 (4.0) | 2 (6.5) | 3 (5.4) | 0.1336 | 0.6342 |
| Previous ischemic stroke/TIA | 6 (9.5) | 10 (17.2) | 16 (13.2) | 2 (3.4) | 3 (5.4) | 5 (4.4) | 2 (8.0) | 3 (9.7) | 5 (8.9) | 0.9085 | 0.0491 |
| Pre-ICH mRS score = 1# | 9 (14.3) | 9 (15.5) | 18 (14.9) | 2 (3.4) | 5 (8.9) | 7 (6.1) | 3 (12.0) | 3 (9.7) | 6 (10.7) | 0.5332 | 0.0858 |
| Severity Scores | |||||||||||
| GCS score | 15 (14–15) | 15 (14–15) | 15 (14–15) | 13 (12–15) | 13 (11–14) | 13 (12–15) | 13 (10–14) | 12 (9–13) | 13 (10–14) | 0.4299 | <.0001 |
| NIHSS score | 9 (7–13) | 9 (7–12) | 9 (7–12.5) | 14 (8–17) | 17 (12–20) | 15 (10–19) | 18 (15–20) | 16 (12–19) | 17 (14–19) | 0.0162 | NA |
| ICH score>21 | 0 | 0 | 0 | 0 | 0 | 0 | 6 (24.0) | 8 (25.8) | 14 (25.0) | ||
| Laboratory and Imaging Data | |||||||||||
| Blood glucose2, mg/dL | 151.70± 62.33 | 154.59± 60.44 | 153.09± 61.19 | 136.55± 38.51 | 157.50± 74.63 | 146.84± 59.74 | 148.47± 31.90 | 150.93± 43.30 | 149.83± 38.32 | 0.6509 | 0.3692 |
| ICH Location: Lobar Deep (thalamic) Deep (non-thalamic) | |||||||||||
| 1 (1.6) | 4 (6.9) | 5 (4.1) | 13 (22.4) | 8 (14.3) | 21 (18.4) | 12 (48.0) | 21 (67.7) | 33 (58.9) | 0.0703 | <.0001 | |
| 32 (50.8) | 34 (58.6) | 66 (54.5) | 13 (22.4) | 23 (41.1) | 36 (31.6) | 1 (4.0) | 3 (9.7) | 4 (7.1) | 0.5651 | <.0001 | |
| 30 (47.6) | 20 (34.5) | 50 (41.3) | 32 (55.2) | 25 (44.6) | 57 (50.0) | 12 (48.0) | 7 (22.6) | 19 (33.9) | 0.5638 | 0.1314 | |
| ICH volume3, mL | 5.47 (2.89–7.94) | 5.99 (3.86–7.71) | 5.78 (3.51–7.72) | 17.67 (13.97–23.48) | 16.23 (13.01–20.51) | 17.05 (13.04–21.77) | 49.70 (38.32–59.22) | 52.52 (36.41–67.12) | 51.63 (36.88–62.49) | ||
| Presence of IVH | 23 (36.5) | 28 (48.3) | 51 (42.1) | 19 (32.8) | 27 (48.2) | 46 (40.4) | 10 (40.0) | 13 (41.9) | 23 (41.1) | 0.6981 | 0.9466 |
| IVH volume4, mL | 0.00 (0.00–4.52) | 0.00 (0.00–6.06) | 0.00 (0.00–4.67) | 0.00 (0.00–1.34) | 0.00 (0.00–9.14) | 0.00 (0.00–5.43) | 0.00 (0.00–0.23) | 0.00 (0.00–1.17) | 0.00 (0.00–0.97) | ||
| Intubation | 7 (11.1) | 4 (6.9) | 11 (9.1) | 10 (17.2) | 20 (35.7) | 30 (26.3) | 8 (32.0) | 13 (41.9) | 21 (37.5) | 0.1524 | <.0001 |
#
Only patients with pre-ICH mRS score 0–1 were recruited into the iDEF trial.
1
p-values not provided for ICH score due to data sparsity.
2
p-values based on inverse transformation of blood glucose to correct non-normality of residuals.
3
p-values not provided for ICH volume due to collinearity with hematoma volume category.
4
p-values not provided for continuous IVH volumne due to non-normaility of residuals.
DFO = Deferoxamine