TBI: Trials and Tribulations, page-18

Results are in for the Phase 3 trial of erythropoietin (EPO) in TBI.

Experimental evidence and supportive evidence from previous clinical trials had suggested a possible beneficial effect of EPO in TBI. However, its use has been limited because of concerns that it may increase thrombosis in critically ill patients.

The trial was conducted in a collaboration between the Australian and New Zealand Intensive Care Society Clinical Trials Group and the Australian and New Zealand Intensive Care Research Centre. Findings of the research were presented at this month’s 28th Annual European Society of Intensive Care Medicine Congress and have also been published in The Lancet.

The double-blind, placebo-controlled trial of 606 patients in 7 countries took four and a half years to complete. The primary outcome, assessed at 6 months, was improvement in the patients' neurological status, summarised as a reduction in the proportion of patients, measured by the Extended Glasgow Outcome Scale (GOS-E) of 1–4 (death, vegetative state, and severe disability). Thromboembolic events were also measured.

EPO did not demonstrate improvement in functional outcome at six months as  shown by a reduction in the number of patients with an GOS-E measure of 4 or lower (134 [44%] of 302 patients in the EPO group vs 132 [45%] of 294 in the placebo group; relative risk [RR] 0·99 [95% CI 0·83–1·18], p=0·90).

In terms of safety, EPO did not significantly increase the occurrence of deep venous thrombosis of the lower limbs (48 [16%] of 305 vs 54 [18%] of 298; RR 0·87 [95% CI 0·61–1·24], p=0·44).

The effect of EPO on mortality remains inconclusive. Although the effect of EPO on 6-month mortality versus placebo did not reach statistical significance, a reduction in death was observed (32 [11%] of 305 patients had died at 6 months in the erythropoietin group vs 46 [16%] of 297 [16%] in the placebo group; RR 0·68 [95% CI 0·44–1·03], p=0·07).

Leader of the research, Professor Alistair Nichol, said that the study would appear to rule out calls for
routine use of EPO in patients with TBI.  
  

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00386-4/abstract

http://www.ucd.ie/medicine/news/october2015/title,254373,en.html

http://www.esicm.org/blog/?p=271

https://clinicaltrials.gov/ct2/show/NCT00987454?term=tbi, erythropoietin&rank=2

http://monash.edu/news/show/monash-...-breaking-discovery-for-major-trauma-patients