EUCTR2011-005235-22-DE
Active, not recruiting
Not Applicable
Erythropoietin in Traumatic Brain Injury (EPO-TBI) - EPO-TBI
ConditionsTraumatic brain injuryMedDRA version: 14.1Level: PTClassification code 10019196Term: Head injurySystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]
DrugsErypo
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- MONASH UNIVERSITY
- Enrollment
- 606
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:
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
Investigators
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