ANZICS CTG Endorsed Study
Long term effects of erythropoietin in patients with moderate to severe traumatic brain injury. A follow-up study of an international randomised controlled trial
Between 2010 and 2014 the EPO TBI study was conducted in Australia, New Zealand, Saudi Arabia, France, Finland, Germany and Ireland. A total of 606 patients with moderate to severe traumatic brain injury (TBI) treated in the intensive care unit were randomly given either subcutaneous erythropoietin (EPO) or placebo once a week for three weeks or until intensive care unit discharge. The study was published in October 2015 and showed no difference regarding neurological recovery, but with further analysis a possible difference in mortality at 6 months was noted.
In the current study we aim to study the long term outcome of the patients included in the EPO TBI study. We aim to check, at a variable time point 2 to 7 years from injury, the survival status of the included patients. Patients that are alive will be contacted and invited to participate in an interview in order to determine present neurological recovery and quality of life. If the patient is unable to take part in the interview we will, as in the primary study contact the person responsible. Written consent will be obtained in those participating. In the interview conducted by a trained assessor of neurological function and quality of life using approved standardised methods.
The study will give important information on the longterm effects of EPO after TBI. Risks for participants can be considered to be low and participation in the neurological follow-up will be based on informed consent. By checking survival status of participants prior to contact, we can avoid contacting relatives of deceased patients.
Rinaldo Bellomo (Chair), Yaseen Arabi, Jamie Cooper, Craig French, Olivier Huet, Lorraine Little (Project Manager), Nora Luethi, Alistair Nichol, Jeffrey Presneill, Markus Skrifvars, and Shirley Vallance.
ANZIC Research Centre, Monash University
Irish Clinical Trials Group, Assistance Publique Hopitaux De Paris.
ANZIC Research Centre $80,000
Project Status as of June 2018
Approval of protocol amendment to allow for informed consent over the phone in Australian participants and for waiver of consent from AIHW ethics committee to allow linkage with National Death Index (NDI) in Australia. Paper and electronic CRFs have been finalized (RedCap database for referral forms and outcome assessment).
We currently have governance approval at five Australian sites and we have started data collection for linkage with the National Death Index (NDI).
We have protocol approval in New Zealand, ethics approval and contracts are currently prepared with Kingdom of Saudi Arabia. Ethics submission preparation is underway in France, Finland and Ireland.