EPO-TBI Long-Term Follow-Up Study

EPO-TBI

EPO-TBI Long-Term Follow-Up 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.

Traumatic brain injury (TBI) is a catastrophic event that commonly requires treatment in an intensive care unit. Management is mainly supportive, aiming at avoiding hypoxia, hypotension, hypoglycaemia and increased intracerebral pressure. Thus far efforts to find specific pharmacologic therapies have been disappointing. Recently we demonstrated that recombinant erythropoietin has been found to decrease mortality at six months from injury but without significantly improving functional neurological outcome (GOS-E). Whether this survival benefit of EPO is sustained beyond 6 months is unknown. In addition, little is known about the mechanism of the observed decrease in mortality. In this follow-up study of the EPO-TBI study (The Lancet 2015) we aim to analyse long-term (beyond 6 months) outcomes, including quality of life and time of death in those who died. Survival data will be collected centrally and surviving patients will be invited to participate in an evaluation of neurological function and quality of life. We will model factors associated with cause and time to death, as well as factors associated with long-term quality of life. The study will provide important information on whether EPO influences long-term outcomes after TBI.

Aims: In this post hoc study of a randomised controlled trial our primary aim is to determine the effect of EPO compared to placebo in improving outcome, including survival, neurological function and quality of life two years after the conclusion of the EPO-TBI study (three to eight years after moderate or severe TBI occurring in individual patients).

Primary outcome: Mortality and time to mortality at least 2 years from injury.

Study Progress: Patient recruitment commenced in August 2018. 523 patients will be followed up in Australia, Finland, France, Ireland, New Zealand and Saudi Arabia.

Registration: ClinicalTrials.gov (NCT03061565) https://clinicaltrials.gov/ct2/show/NCT03061565

Contact: For further information about this study, please contact the Research Manager, Tony Trapani by email.

Chief Investigators: The Chief Investigators of the study are Dr Nora Luethi and Professor Markus Skrifvars.