Erythropoeitin to facilitate stroke recovery

• Research type

  Research Study

• Full title

  Evaluation of the feasibility of modulating and measuring endogenous neurogenesis with erythropoietin (rhEPOa) to expedite recovery after stroke

• IRAS ID

  71432

• Sponsor organisation

  King's College Hospital NHS Foundation Trust

• Eudract number

  2011-000123-33

• ISRCTN Number

  xx

• Research summary

  Stroke affects 110,000 people every year and is a common cause of adult disability. Although rehabilitation has made a significant difference, the search is on for treatments that can reduce this burden even further. Replacing cells lost in stroke is a novel physiological approach to improve recovery, especially as research shows that the human brain produces new cells throughout life and this production is increased in stroke. Furthermore, animal studies have shown that increased production of brain cells and their integration into brain circuits improves recovery in stroke and can be enhanced with drugs. One such drug, erythropoietin or EPO, is commonly available and used routinely to stimulate blood production in patients with anaemia or kidney disease. The main aim of this study is to test the principle that EPO in a safe dose given during rehabilitation can improve recovery from stroke. The research will be undertaken in 3 groups of 30 stroke patients each who are within 48 hours of stroke onset, have not been thrombolysed and have no contraindications to EPO treatment. All groups will receive best usual treatment consisting of structured multidisciplinary rehabilitation on a stroke unit. In addition, participants in the second group will receive EPO 40,000 IU given intravenously at 1, 3 and 5 days and those in the third group will receive EPO 40,000 IU/ given intravenously at 7, 14, 21 days. The differences in recovery between the groups will be assessed at 30 and 90 days after randomisation by measuring clinical recovery in function and changes in the brain perfusion and structure using magnetic resonance (MR) imaging. The research will tell us whether EPO treatment given early or late during stroke recovery has the potential to improve recovery in stroke patients who have not been thrombolysed. If EPO is shown to have the potential to flunce brain repair, information from the study will be used to design larger definitive clinical trials for translation into clinical use in 3-5 years.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  11/LO/0346

• Date of REC Opinion

  1 Jun 2011

• REC opinion

  Further Information Favourable Opinion