Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT02148367
Eligibility Criteria:
Inclusion Criteria:
* Age 18 - 70 years, inclusive
* History of having sustained a TBI \> 3 days and \< 7 days prior to enrollment. This evidence will be any one of the following:
1. GCS 3 - 12 on first presentation to medical attention
2. Post-traumatic amnesia \> 24 hours
3. TBI-related abnormality on neuroimaging
* Persistent post-concussive symptoms
1. Three of more of the following symptoms, which started shortly after the trauma and persist for at least up to the time of enrollment:
* Fatigueability
* Disordered sleep
* Headache
* Vertigo or dizziness
* Irritability or aggression
* Anxiety, depression, or affective instability
* Changes in personality (e.g., social or sexual inappropriateness)
* Apathy or lack of spontaneity
2. Symptoms had their onset after trauma, or there is a significant worsening or pre-existing symptoms after trauma.
* Ability to give consent by the participant himself
* Willingness of women of childbearing potential to use effective contraception during this
Exclusion Criteria:
* Contraindication to EPO therapy:
1. Known allergy to EPO, hypersensitivity to mammalian cell-derived products, or hypersensitivity to albumin
2. Serum hemoglobin \> 16 g/dL in a male patient or \> 14 g/dL in a female patient; or a platelet count \> 400,000/mm3 or serum hemoglobin \< 10 g/dL in either a male or female patient
3. liver or kidney disease; the former will be operationally defined as a serum bilirubin \> 4 mg/dL, alkaline phosphatase (AP) \> 250 U/L, aspartate aminotransferase (SGOT, AST) \> 150 U/L, alanine aminotransferase (SGPT, ALT) \>150 U/L, or Moderately decreased GFR 30-59 ml/min/1.73m2
4. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female of childbearing potential
* Use of EPO one month prior to the randomization
* Suspicion of a coagulation disorder associated with bleeding (PTT\>45 or INR\>1.7, spontaneously out of normal range)
* Pre-existing and active major disabling psychiatric disorder (e.g., schizophrenia or bipolar disorder), or other neurological disease (epilepsy, multiple sclerosis, developmental disorder) not related to TBI
* History of heart disease or heart attack, congestive heart failure, stroke, venous thromboembolism.
* History of disorders that predispose to coagulation (e.g. polycythemia vera, essential thrombocytosis, or thrombotic thrombocytopenic purpura).
* Uncontrolled hypertension, defined as above 140/90 mm Hg in three measurements in two separate visits despite antihypertensive therapy.
* Known malignant conditions, e.g., melanoma, breast, brain, lung tumor or prostate cancer
* Terminal medical diagnosis consistent with survival \< 1 year
* Planned surgical procedure during duration of the study
* Current use of Coumadin or other blood thinners (e.g. Pradaxa, Heparin, Lovenox).
* Any history of previous deep venous thrombosis (DVT), pulmonary embolization (PE), or other thromboembolic event
* Current participation in other interventional clinical trial
* Current use of iron supplements
* Evidence of penetrating brain injury
* Contraindication to MRI scanning
* No adherence to use of effective method of contraception for females of childbearing potential for time from enrollment to the study until 2 weeks after completion of the study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02148367
Study Brief:
Protocol Section:
NCT02148367