A study to see if erythropoietin can help patients recover better from headinjury.

• Conditions: Traumatic brain injury; MedDRA version: 14.1Level: PTClassification code 10019196Term: Head injurySystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2011-005235-22-IE
• Lead Sponsor: MONASH UNIVERSITY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-10
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 606

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
enrolment
Not in the best interest of the patient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified