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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

February 14, 2017
February 23, 2017
August 22, 2018
August 1, 2017
May 31, 2019   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03061565 on ClinicalTrials.gov Archive Site
  • Glasgow outcome scale extended [ Time Frame: 2-7 years from injury ]
    Neurological outcome
  • SF-12 [ Time Frame: 2-7 years from injury ]
    Quality of life scale
  • EQ-5D [ Time Frame: 2-7 years from injury ]
    Quality of life scale
Same as current
Not Provided
Not Provided
 
Long Term Effects of Erythropoietin in Patients With Moderate to Severe Traumatic Brain Injury
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.

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
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Traumatic Brain Injury
  • 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
  • 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
  • Erythropoietin
    Patients were treated with EPO during the EPO-TBI study in 2010-2014.
    Intervention: Drug: erythropoietin
  • Placebo
    Patients were treated with placebo during the EPO-TBI study in 2010-2014.
    Intervention: Drug: Placebos
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
603
Same as current
May 31, 2019
May 31, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
15 Years to 75 Years   (Child, Adult, Older Adult)
No
Contact: Markus B Skrifvars +61399030343 markus.skrifvars@monash.edu
Contact: Lorraine Little +61399030513 lorraine.little@monash.edu
Australia
 
 
NCT03061565
ANZIC-RC EPO-TBI Long term
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
David James Cooper, Australian and New Zealand Intensive Care Research Centre
Australian and New Zealand Intensive Care Research Centre
Monash University
Principal Investigator: Rinaldo Bellomo ANZIC-RC Monash University
Australian and New Zealand Intensive Care Research Centre
August 2018