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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
  1. EPO Erythropoietin; TBI Traumatic brain injury; GCS Glasgow Coma Scale; GCS-E Extended Glasgow Coma Scale; IU International unit; IV Intravenous; RCT Randomized controlled trial; SC Subcutaneously; DAI Diffuse axonal injury; DRS Disability Rating Scale; FU Follow-up; ICP Intracranial pressure; ICU intensive care unit; NR Not reported; NSE Neuron specific enolase; rhEPO Recombinant human EPO
  2. *Age was reported as median (range) in the studies of Nichol et al., 2015, and Robertson et al., 2014; age was reported as mean ± SD in the studies of Bai et al. 2018, Li et al. 2016, Nirula et al., 2010, Aloizos et al., 2015, and Abrishamkar et al., 2012