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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03061565




Registration number
NCT03061565
Ethics application status
Date submitted
14/02/2017
Date registered
23/02/2017
Date last updated
3/10/2023

Titles & IDs
Public title
Long Term Effects of Erythropoietin in Patients With Moderate to Severe Traumatic Brain Injury
Scientific title
Long Term Effects of Erythropoietin in Patients With Moderate to Severe Traumatic Brain Injury A Follow-up Study of an International Randomised Controlled Trial
Secondary ID [1] 0 0
ANZIC-RC EPO-TBI Long term
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - erythropoietin
Treatment: Drugs - Placebos

Erythropoietin - Patients were treated with EPO during the EPO-TBI study in 2010-2014.

Placebo - Patients were treated with placebo during the EPO-TBI study in 2010-2014.


Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mortality and time to mortality at least 2 years from injury
Timepoint [1] 0 0
2-7 years from injury
Secondary outcome [1] 0 0
Glasgow outcome scale extended
Timepoint [1] 0 0
2-7 years from injury
Secondary outcome [2] 0 0
SF-12
Timepoint [2] 0 0
2-7 years from injury
Secondary outcome [3] 0 0
EQ-5D
Timepoint [3] 0 0
2-7 years from injury

Eligibility
Key inclusion criteria
* Participation in the EPO-TBI study without withdrawal of informed consent.
Minimum age
15 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Failure to to consent for the conduction of the follow-up assessment.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2022
Sample size
Target
Accrual to date
Final
356
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Australian and New Zealand Intensive Care Research Centre, Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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 website
https://clinicaltrials.gov/study/NCT03061565
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rinaldo Bellomo
Address 0 0
ANZIC-RC Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03061565