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Clinical Trials/EUCTR2011-005235-22-DE
EUCTR2011-005235-22-DEActive, not recruitingNot Applicable

Erythropoietin in Traumatic Brain Injury (EPO-TBI) - EPO-TBI

MONASH UNIVERSITY0 sites606 target enrollmentStarted: October 4, 2012Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
606
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Patients with non-penetrating moderate (GCS 9-12) or severe (GCS 3-8)
  • •TBI admitted to the ICU who:
  • •Are = 15 to = 65 years of age
  • •Are < 24 hours since primary traumatic injury
  • •Are expected to stay = 48 hours
  • •Have a haemoglobin not exceeding the upper limit of the applicable
  • •normal (ULN) reference range in clinical use at the treating institution
  • •Have written informed consent from legal surrogate
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 600
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •GCS = 3 and fixed dilated pupils
  • •History of DVT, PE or other thromboembolic event
  • •Chronic hypercoagulable disorder, including known malignancy
  • •EPO in the last 30 day
  • •Pregnancy or lactation or 3 months post partum
  • •Uncontrolled hypertension
  • •Acute myocardial infarct within the past 12 months
  • •Past history of epilepsy with seizures in past 3 months
  • •Expected to die imminently
  • •Inability to perform lower limb ultrasounds
  • •lKnown sensitivity to mammalian cell derived products
  • •Hypersensitivity
  • •Pure red cell aplasia
  • •End stage renal failure
  • •Severe pre-existing physical or mental disability or severe co-morbidity
  • •Treatment with any investigational drug within 30 days before
  • •Not in the best interest of the patient

Investigators

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