Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Long Term Effects of Erythropoietin in Patients With Moderate to Severe Traumatic Brain Injury A Follow-up Study of an International Randomised Controlled Trial

ID
Name
ANZIC-RC EPO-TBI Long term
Description
Traumatic brain injury is catastrophic event that commonly require 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 a specific pharmacologic therapies have been disappointing. Recently it was demonstrated that recombinant erythropoietin has been found to decrease mortality at six months from injury but without significantly improving functional neurological outcome (GOSe). Whether this survival benefit of EPO is sustained beyond 6 months is unknown. In the current study survival data will be collected centrally and patients alive or person responsible will be invited to participate in an evaluation of neurological function and quality of life. Factors associated with time to death as well as factors associated with long term quality of life will be determined with statistical methods.
Trial arms
Trial start
2017-08-01
Estimated PCD
2022-07-01
Trial end
2022-12-31
Status
Completed
Treatment
erythropoietin
Patients were given erythropoietin during the EPO-TBI study in 2010-2014. In the current follow-up we will evaluate any possible long term differences between patients treated with etrythropoietin compared to placebo.
Arms:
Erythropoietin
Other names:
EPOETIN ALFA
Placebos
Patients were given placebo during the EPO-TBI study in 2010-2014. In the current follow-up we will evaluate any possible long term differences between patients treated with etrythropoietin compared to placebo.
Arms:
Placebo
Other names:
Sodium chloride
Size
356
Primary endpoint
Mortality and time to mortality at least 2 years from injury
2-7 years from injury
Eligibility criteria
Inclusion Criteria: * Participation in the EPO-TBI study without withdrawal of informed consent. Exclusion criteria: * Failure to to consent for the conduction of the follow-up assessment.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 356, 'type': 'ACTUAL'}}
Updated at
2023-10-03

1 organization

2 products

1 indication

Organization
Australian and New Zealand Intensive Care Research Centre
Product
erythropoietin
Indication
Traumatic Brain Injury
Product
Placebos