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Erythropoietin in Traumatic Brain Injury (EPO-TBI)

NCT00987454 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 606

Last updated 2016-07-26

No results posted yet for this study

Summary

This study seeks to determine if erythropoietin alpha (EPO) administered to adult critical care patients with moderate or severe traumatic brain injury improves neurological function assessed at six months after injury.

Conditions

Interventions

DRUG

Epoetin Alfa

40,000 IU given as subcutaneous injection weekly up to 3 doses

DRUG

Sodium Chloride 0.9%

1 m/L given as subcutaneous injection weekly up to 3 doses

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Australian and New Zealand Intensive Care Society Clinical Trials Group

    collaborator NETWORK

  • Monash University

    collaborator OTHER

  • Australian and New Zealand Intensive Care Research Centre

    lead OTHER

Principal Investigators

  • Alistair D Nichol, MD · Monash University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Australia
  • Finland
  • France
  • Germany
  • Ireland
  • New Zealand
  • Saudi Arabia

Study Locations

More Related Trials

Entities

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 NCT00987454 on ClinicalTrials.gov