ANZICS CTG Endorsed Study

EPO TBI Long Term Follow Up

Long term effects of erythropoietin in patients with moderate to severe traumatic brain injury. A follow-up study of an international randomised controlled trial

Study Description

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.

Management Committee

Rinaldo Bellomo (Chair), Yaseen Arabi, Jamie Cooper, Craig French, Olivier Huet, Lorraine Little, Nora Luethi, Alistair Nichol, Jeffrey Presneill, Markus Skrifvars, Shirley Vallance, Tony Trapani, Joanne Brooker

Administering Institution

ANZIC Research Centre, Monash University

Sample Size

517 patients

Funding

ANZIC Research Centre

Reference

CTG1617-10, NCT03061565

Contact

Tony Trapani (email)