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Long Term Effects of Erythropoietin in Patients With Moderate to Severe Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT03061565
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
Monash University
Information provided by (Responsible Party):
David James Cooper, Australian and New Zealand Intensive Care Research Centre

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.


Condition or disease Intervention/treatment
Traumatic Brain Injury Drug: erythropoietin Drug: Placebos

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 Type : Observational
Estimated Enrollment : 603 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Erythropoietin
Patients were treated with EPO during the EPO-TBI study in 2010-2014.
Drug: 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.
Other Name: EPOETIN ALFA

Placebo
Patients were treated with placebo during the EPO-TBI study in 2010-2014.
Drug: 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.
Other Name: Sodium chloride




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Glasgow outcome scale extended [ Time Frame: 2-7 years from injury ]
    Neurological outcome

  2. SF-12 [ Time Frame: 2-7 years from injury ]
    Quality of life scale

  3. EQ-5D [ Time Frame: 2-7 years from injury ]
    Quality of life scale



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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061565


Contacts
Contact: Markus B Skrifvars +61399030343 markus.skrifvars@monash.edu
Contact: Lorraine Little +61399030513 lorraine.little@monash.edu

Locations
Australia, Victoria
Australian and New Zealand Intensive Care Research Centre, Monash University Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Lorraine Little    +61 3 9903 0513    lorraine.little@monash.edu   
Sponsors and Collaborators
Australian and New Zealand Intensive Care Research Centre
Monash University
Investigators
Principal Investigator: Rinaldo Bellomo ANZIC-RC Monash University

Responsible Party: David James Cooper, Director, Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov Identifier: NCT03061565     History of Changes
Other Study ID Numbers: ANZIC-RC EPO-TBI Long term
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David James Cooper, Australian and New Zealand Intensive Care Research Centre:
erythropoietin
traumatic brain injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Epoetin Alfa
Hematinics