Table 2.
EPO Trial Results
| A) EPO Trial #1[56] | ||
|---|---|---|
| Criteria | Treatment Groups- Double-Blind |
|
| EPO | Placebo | |
| Age range | 39–80 (mean 68) | 49–79 (mean 63) |
| Sex | 15 males 6 female |
13 male 6 female |
| Time to Treatment (minutes) | 160–475 (mean 300) | 200–465 (mean 285) |
| Stroke Subtype (%) | ||
| • cardioembolic | 42.9 | 52.6 |
| • small vessel | 14.3 | 14.3 |
| • large vessel | 19.0 | 23.8 |
| • other | 23.8 | 22.2 |
| Stroke Severity | ||
| • SSS | 8–52 (mean 30) | 6–54 (mean 30) |
| • NIHSS | 3–26 (mean 11) | 1–28 (mean 13) |
| Stroke Outcome | ||
| • SSS | Improvement at day 7, 18 and 30 (p<0.03-p<0.001) 9 point increase |
Mean 30 increased to 35 on day 30 |
| • NIHSS | Improvement by day 18 and 30 (p<0.03-p<0.09) 4 point decrease |
Mean 13 was stable with variability for duration |
| • mRS (Rank) | ||
| 5–6 | 14%* | 37% |
| 3–4 | 33%* | 21% |
| 2 | 5%* | 16% |
| 1 | 33% | 5% |
| 0 | 14% | 21% |
| • BI (Rank)# | 14% | 42% |
| 0–20 | 14% | 5% |
| 21–30 | 10% | 5% |
| 41–60 | 5% | 5% |
| 61–80 | 57% | 42% |
| 81–100 | ||
| Mortality Rate ND | ND | |
| B) EPO Trial #2[51] | ||||
|---|---|---|---|---|
| Criteria | Treatment Groups- Double-Blind |
|||
| EPO | EPO/tPA | Placebo | tPA | |
| Age range | 38–95 (mean 71.9) | 20–100 (mean 66.8) | 42–92 (mean 71.5) | 19–95 (mean 61.2) |
| Sex | 49 males 41 female |
92 males 74 females |
48 male 53 female |
93 male 72 female |
| Time to Treatment (minutes) | 42–442 (mean 271) | 45–410 (mean 263) | 78–485 (mean 281) | 110–480 (mean 267) |
| Stroke Subtype (%) | ||||
| • cardioembolic | 50 | 51.2 | 47.5 | 44.2 |
| • small vessel | 6.7 | 3.0 | 5.9 | 1.8 |
| • large vessel | 21.1 | 23.5 | 19.8 | 27.3 |
| • other | 22.2 | 22.3 | 22.2 | 26.7 |
| Stroke Severity | ||||
| • NIHSS | 4–32 (mean 13) | 4–31 (mean 13.3) | 14–27 (mean 11.7) | 4–30 (mean 13.5) |
| Stroke Outcome | ||||
| • NIHSS | No improvement at either 30 or 90 (p>0.05)day | No improvement at either day 30 or 90 (p>0.05) | ||
| Day 1 | 13.0 ± 6.4 | 13.3 ± 5.5 | 11.7 ± 5.5 | 13.5 ± 5.8 |
| Day 30 | 10.7 ± 12 | 11.6 ± 12 | 10.3 ± 10 | 8.8 ± 11 |
| Day 90 | 10.2 ± 12 | 9.5 ± 12 | 9.1 ± 9 | 7.7 ±10 |
| • mRS | No improvement at either day 30 or 90 (p>0.05) | No improvement at either day 30 or 90 (p>0.05) | ||
| Day 30 | 3.6 ± 1.9 | 3.4 + 2.0 | 3.6 ± 1.7 | 3.2 ± 2.0 |
| Day 90 | 3.5 ± 3.3 | 3.1 ± 2.0 | 3.3 ± 1.8 | 2.9 ± 2.0 |
| • BI | No change at either day 30 or 90 (p>0.05) | No change at either day 30 or 90 (p>0.05) | ||
| Day 30 | 47.0 ± 43 | 50.8 ± 48 | 45.6 ± 40 | 54.9 ± 43 |
| Day 90 | 50.9 ± 42 | 59.5 ± 41 | 52.2 ± 41 | 63.5 ± 41 |
| Mortality Rate | 16.4%* | 16.3%* | 9.0% | 8.5% |
*
p<0.07 on day 30;
#
p<0.05 on day 30;
NA- not described.
*
p<0.01