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Completed

NCT Number: NCT03061565

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Australian and New Zealand Intensive Care Research Centre, Monash University

Melbourne, Victoria, 3004, Australia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erythropoietin

Drug

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 names: EPOETIN ALFA

Placebos

Drug

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 names: Sodium chloride

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Australian and New Zealand Intensive Care Research Centre

Other

Collaborators

  • Monash University

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2017
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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