Table 2.
Primary outcomes and selected secondary outcomes by treatment group.
| Measurement | Level | Anakinra | Placebo | Mean difference (95% CI) |
|---|---|---|---|---|
| Oedema extension distance | −0.05 (−0.17, 0.06) a | |||
| Baseline |
N
Mean (SD) |
14 0.33 (0.12) |
11 0.35 (0.10) |
|
| 72 h |
N
Mean (SD) |
13 0.49 (0.15) |
11 0.55 (0.18) |
|
| Mean change (72 h – Baseline) |
N
Mean (SD) |
13 0.15 (0.12) |
11 0.20 (0.14) |
|
| Early Neurological Decline | p = 1.0 b | |||
| Participants with data | N | 14 | 11 | |
| Yes | N (%) | 1 (7%) | 0 | |
| No | N (%) | 13 (93%) | 11 (100%) | |
| Haematoma Expansion | p = 0.482 b | |||
| Participants with data | N | 13 | 11 | |
| Yes | N (%) | 2 (15%) | 0 (0%) | |
| Yes (>33% increase) | N (%) | 2 (15%) | 0 (0%) | |
| Yes (> 6mL increase) | N (%) | 1 (8%) | 0 (0%) | |
| No | N (%) | 11 (85%) | 11 (100%) | |
| Modified Rankin Scale (mRS) at 3 months | OR 3.3 (0.6, 19.3) c |
|||
| Participants with data | N | 12 | 10 | |
| 0 | N (%) | 0 | 0 | |
| 1 | N (%) | 2 (17%) | 2 (20%) | |
| 2 | N (%) | 1 (8%) | 3 (30%) | |
| 3 | N (%) | 2 (17%) | 2 (20%) | |
| 4 | N (%) | 3 (25%) | 3 (30%) | |
| 5 | N (%) | 3 (25%) | 0 | |
| 6 | N (%) | 1 (8%) | 0 | |
a
Difference in 72 h OED adjusted for baseline OED using ANCOVA. Kineret – placebo is shown.
b
Fisher’s exact test.
C
mRS was dichotomised as good outcome (0 –3) and poor outcome (4 –6) for comparison by logistic regression, odds ratio of poor outcome, compared to good outcome, and 95% CI displayed.