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

NCT03061565 | Completed

• 1 other identifier: ANZIC-RC EPO-TBI Long term
• Study Type: observational
• Target: 356
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

erythropoietin; traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Glasgow outcome scale extended

  2-7 years from injury

• SF-12

  2-7 years from injury

• EQ-5D

  2-7 years from injury

Study Arms (2)

Erythropoietin

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

Drug: erythropoietin

Placebo

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

Drug: Placebos

Interventions

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.

Also known as: EPOETIN ALFA

Erythropoietin

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.

Also known as: Sodium chloride

Placebo

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participation in the EPO-TBI study without withdrawal of informed consent.

You may not qualify if:

• Failure to to consent for the conduction of the follow-up assessment.

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead
• Monash University: collaborator

Study Sites (1)

Australian and New Zealand Intensive Care Research Centre, Monash University

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Erythropoietin; Epoetin Alfa; Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Rinaldo Bellomo

  ANZIC-RC Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 23, 2017
• Study Start: August 1, 2017
• Primary Completion: July 1, 2022
• Study Completion: December 31, 2022
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)