Traumatic Brain InjuryNCT03061565
Long Term Effects of Erythropoietin in Patients With Moderate to Severe Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Australian and New Zealand Intensive Care Research Centre at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- erythropoietin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 356 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Aug 2017to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The EPO-TBI study conducted between 2010 and 2015 enrolled a total of 606 patients treated for moderate to severe traumatic brain injury in the intensive care unit. Of these consent was withdrawn in 3 patients. Of the 603 patients, 524 we alive at 6 months. Survival status will be checked in these 524 patients and those alive will be included in a follow-up of functional recover and quality of life.
Who may be able to join
- Participation in the EPO-TBI study without withdrawal of informed consent.
Who cannot join
- Failure to to consent for the conduction of the follow-up assessment.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Australian and New Zealand Intensive Care Research Centre, Monash University
Melbourne, Victoria, 3004
About this study
Official 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
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.
Read the detailed description
Aim: In this post hoc study of a RCT the 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 (two to seven years after moderate or severe TBI occurring in individual patients).
Design: A long term follow-up study of a prospective, multi-centre, double blind, phase III, randomised controlled trial.
Methods: Survival status at the time when this follow-up trial is executed will obtained in all patients. Time from injury will vary between 2 to 7 years depending on when the patient was enrolled. This information will obtained from hospital notes, national register offices and/or national statistical bureaus. Since the trial was an international RCT, strategies may vary and will take into account local circumstances. Local plans will be developed by the local principal investigators and approved by the management committee.
Data includes
- Survival status at long term follow up (alive/dead)
- Time from injury to assessment (days)
- If the patients is deceased, time of death and time from injury in days
Quality of life assessment
Patients (or a proxy - generally a close family member) who are alive at 2-7 years after randomisation will be interviewed by trained assessors. The same contact person as used in the primary trial will be contacted primarily. Consent will be obtained for the conduction for long term assessment. Assessors will use a standardized structured telephone questionnaires to determine GOSE and QOL. Neurological outcomes will then be defined as favourable (GOSE 5 to 8; moderate disability and good recovery) or unfavourable (GOSE 1 to 4; death and severe disability). Data include:
- Time of assessment
- Time from injury in days
- Follow-up GOSE
- Follow-up EQ-5D
- Follow-up SF-12
- Conditions
- Traumatic Brain Injury
- Being tested
- erythropoietin, Placebos
- Keywords
- erythropoietin, traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythropoietinDrug
Also called EPOETIN ALFA
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.
PlacebosDrug
Also called Sodium chloride
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.
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin | Patients were treated with EPO during the EPO-TBI study in 2010-2014. Receives: Drug: erythropoietin | |
| Placebo | Patients were treated with placebo during the EPO-TBI study in 2010-2014. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality and time to mortality at least 2 years from injury
Survival status with time to death in those deceased
Measured: 2-7 years from injury
Secondary outcomes (3)
Glasgow outcome scale extended
Neurological outcome
Measured: 2-7 years from injury
SF-12
Quality of life scale
Measured: 2-7 years from injury
EQ-5D
Quality of life scale
Measured: 2-7 years from injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Aug 2017
- Primary completion1 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Principal investigator, David James Cooper, Australian and New Zealand Intensive Care Research Centre
- Investigators
- Rinaldo Bellomo, Principal investigator, ANZIC-RC Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061565
- Sponsor's protocol ID
- ANZIC-RC EPO-TBI Long term
- Status last verified
- Oct 2023
- First submitted
- 14 Feb 2017
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03061565
- Acronym / sponsor ID
- ANZIC-RC EPO-TBI Long term
- Conditions
- Traumatic Brain Injury
- Keywords
- erythropoietin, traumatic brain injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- Monash University
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim: In this post hoc study of a RCT the 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 (two to seven years after moderate or severe TBI occurring in individual patients).
Design: A long term follow-up study of a prospective, multi-centre, double blind, phase III, randomised controlled trial.
Methods: Survival status at the time when this follow-up trial is executed will obtained in all patients. Time from injury will vary between 2 to 7 years depending on when the patient was enrolled. This information will obtained from hospital notes, national register offices and/or national statistical bureaus. Since the trial was an international RCT, strategies may vary and will take into account local circumstances. Local plans will be developed by the local principal investigators and approved by the management committee.
Data includes
- Survival status at long term follow up (alive/dead)
- Time from injury to assessment (days)
- If the patients is deceased, time of death and time from injury in days
Quality of life assessment
Patients (or a proxy - generally a close family member) who are alive at 2-7 years after randomisation will be interviewed by trained assessors. The same contact person as used in the primary trial will be contacted primarily. Consent will be obtained for the conduction for long term assessment. Assessors will use a standardized structured telephone questionnaires to determine GOSE and QOL. Neurological outcomes will then be defined as favourable (GOSE 5 to 8; moderate disability and good recovery) or unfavourable (GOSE 1 to 4; death and severe disability). Data include:
- Time of assessment
- Time from injury in days
- Follow-up GOSE
- Follow-up EQ-5D
- Follow-up SF-12
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin | – | Drug: erythropoietinPatients were treated with EPO during the EPO-TBI study in 2010-2014. |
| Placebo | – | Drug: PlacebosPatients were treated with placebo during the EPO-TBI study in 2010-2014. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The EPO-TBI study conducted between 2010 and 2015 enrolled a total of 606 patients treated for moderate to severe traumatic brain injury in the intensive care unit. Of these consent was withdrawn in 3 patients. Of the 603 patients, 524 we alive at 6 months. Survival status will be checked in these 524 patients and those alive will be included in a follow-up of functional recover and quality of life.
Key inclusion criteria (1 listed)
- Participation in the EPO-TBI study without withdrawal of informed consent.
Key exclusion criteria (1 listed)
- Failure to to consent for the conduction of the follow-up assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erythropoietinAlso: EPOETIN ALFAPatients 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. | Drug | Erythropoietin |
| PlacebosAlso: Sodium chloridePatients 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. | Drug | Placebo |
Primary outcome
Mortality and time to mortality at least 2 years from injury
Time frame: 2-7 years from injury
Survival status with time to death in those deceased
3 secondary outcomes
Glasgow outcome scale extended
Time frame: 2-7 years from injury
SF-12
Time frame: 2-7 years from injury
EQ-5D
Time frame: 2-7 years from injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rinaldo Bellomo principal investigator
ANZIC-RC Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Australian and New Zealand Intensive Care Research Centre at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality and time to mortality at least 2 years from injury (time frame: 2-7 years from injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.