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

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03061565
• Other study ID #: ANZIC-RC EPO-TBI Long term
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2023
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: December 31, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	Australian and New Zealand Intensive Care Research Centre, Monash University	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre	Monash University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality and time to mortality at least 2 years from injury	Survival status with time to death in those deceased	2-7 years from injury
Secondary	Glasgow outcome scale extended	Neurological outcome	2-7 years from injury
Secondary	SF-12	Quality of life scale	2-7 years from injury
Secondary	EQ-5D	Quality of life scale	2-7 years from injury