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

NCT ID: NCT03061565

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 356 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2022-12-31

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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Erythropoietin

Patients were treated with EPO during the EPO-TBI study in 2010-2014.

erythropoietin

Intervention Type: 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.

Placebo

Patients were treated with placebo during the EPO-TBI study in 2010-2014.

Placebos

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

EPOETIN ALFA; Sodium chloride

Eligibility 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Monash University

OTHER

Sponsor Role: collaborator

Australian and New Zealand Intensive Care Research Centre

OTHER

Sponsor Role: lead

Responsible Party

David James Cooper

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rinaldo Bellomo

Role: PRINCIPAL_INVESTIGATOR

ANZIC-RC Monash University

Locations

Australian and New Zealand Intensive Care Research Centre, Monash University

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

ANZIC-RC EPO-TBI Long term

Identifier Type: -

Identifier Source: org_study_id