Long Term Effects of Erythropoietin in Patients With Moderate to Severe Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational

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.
    

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
    

Intervention name(s): erythropoietin; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): EPOETIN ALFA; Sodium chloride
Intervention MeSH terms: Epoetin Alfa
Observational model: Case-Control
Time perspective: Prospective
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.
      
Keywords: erythropoietin; traumatic brain injury