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

NCT03061565 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 356

Last updated 2023-10-03

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Monash University

    collaborator OTHER

  • Australian and New Zealand Intensive Care Research Centre

    lead OTHER

Principal Investigators

  • Rinaldo Bellomo · ANZIC-RC Monash University

Eligibility

Min Age
15 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2022-07-01
Completion
2022-12-31

Countries

  • Australia

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03061565 on ClinicalTrials.gov