Table 1
From: Efficacy and safety of erythropoietin for traumatic brain injury
Study/Year | Country | Study design | No. of patients | Mean age, y | Male patients, % | EPO vs. Control | Clinical Setting | Interventions | Time from trauma to intervention | Control | Follow-up Duration | Outcome Measures |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Nirula et al, 2010 [25] | USA | Single-center, double-blind RCT | 16 | 36.6 ± 20.7 | 68.6 | 11 vs. 5 | Severe or Moderate TBI: Blunt trauma patients with evidence of TBI on CT, GCS < 13 | EPO 40,000 IU IV | Within 6 h | Equal volume 0.9% NaCl | Discharge from Hospital or dead | Serum s-100B, NSE levels, ICP values, adverse events |
Abrishamkar et al, 2012 [24] | Iran | double-blind RCT | 54 | 26.3 ± 5.2 | 100 | 27 vs. 27 | Severe TBI w/DAI: GCS 4–8, exclude hemorrhage | rhEPO 2000 IU SC for six doses in two weeks (on days: 2, 4, 6, 8 and 10) | Average time was 5 h | Equal volume 0.9% NaCl | Discharge from Hospital or dead | Mean GOS score, length of hospital stay, mortality |
Robertson et al, 2014 [26] | USA | Multie-center, double-blind RCT | 200 | 32.9 ± 17.6 | 86.5 | 102 vs. 98 | TBI: Closed head injury who were unable to follow commands, Glasgow Coma Scale score formotor component ≤5 | Regimen 1: EPO 500 IU/kg per dose IV,1 dose given within 6 h of injury followed by 2 additional doses given every 24 h; regimen 2: EPO 1 dose given within 6 h of injury | Within 6 h | Equal volume 0.9% NaCl over 2 min for each dose | 6 months | GOS score, DRS Score, adverse events |
Aloizos et al, 2015 [23] | Greece | Single-center, open-label RCT | 42 | 36.7 ± 9.1 | 92.9 | 24 vs. 18 | Severe TBI: Blunt head trauma, GCS < 9, or hypotension (systolic blood pressure < 100 mmHg) | EPO 10,000 IU SC for 7 consecutive days | Within 6 h | No placebo treatment | 6 months | GOS-E Score, length of ICU stay, adverse events |
Nichol et al, 2015 [21] | Australia, New Zealand, France, Germany, Finland, Ireland, and Saudi Arabia | Multie-center, double-blind RCT | 606 | 33.8 ± 18.8 | 83.3 | 305 vs. 298 | Severe or moderate TBI: non-penetrating traumatic brain injury (GCS 3–12) | Epoetin alfa 40,000 IU SC once per week for a maximum of three doses | Within 24 h | Equal volume 0.9% NaCl, once per week for a maximum of three doses | 6 months | GOS-E Score, adverse events |
Li et al, 2015 [20] | China | Single-center, open-label RCT | 159 | 42.3 ± 9.9 | 61.6 | 78 vs. 80 | Severe TBI: head trauma plus the worst initial GCS of 7 or less on arrival. | rhEPO subcutaneous injection on the admission day (within2 h of admission), and on day 3,6,9 and 12 after admission, daily dose of 100 units/kg (average 5999 units) | within 5 h | received the same volumes of subcutaneous normal saline on the admission day and on day 3,6,9 and 11 after admission | 2 months | GOS score, Serum s-99B, NSE levels, Blood pressure,hemoglobin levels, adverse events |
Bai et al, 2015 [22] | China | Single-center, open-label RCT | 120 | 43.8 ± 11.1 | 70.8 | 60 vs. 60 | Severe TBI: GCS score less than 8 | rhEPO 6000 IU subcutaneous injection on the admission day (within 2 h of admission), and on day 3,5,10 and 15 after admission | NR | received the same volumes of subcutaneous normal 0.9% saline on the same time | 10 weeks | GOS score, mortality, adverse events |