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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT00561067
Eligibility Criteria:
Inclusion Criteria:
* Traumatic SCI occurred within 8 hours
* Hemodynamic stability at the time of treatment start (systolic blood pressure \> 90 mmHg for at least 1 hour without massive infusion or vasopressor support for ongoing bleeding)
* Neurological level between C5 and T12 (ASIA scale)
* ASIA Impairment Scale: A or B
* Informed consent
Exclusion Criteria:
* SCI other than traumatic
* SCI caused by edged weapons or fire arms
* Traumatic SCI after 8 hours
* Neurological level above C5 or below T12
* ASIA Impairment Scale C, D, E
* Uncontrolled arterial hypertension
* Past or current cerebrovascular disease
* Past or current acute myocardial infarction
* History of thrombotic events
* Other chronic cardiovascular disorders (cardiac arrhythmias, congestive heart failure)
* History of peripheral arterial disease, polycythemia, porphyria, active malignancy
* Previous or current neurological diseases with abnormal neurological examination
* Suspected or definite pregnancy or lactation (requiring ßHCG confirmation)
* Clinically relevant psychiatric disease
* Known allergy to EPO
* Hypersensitivity to human albumin
* Acute or chronic renal failure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00561067
Study Brief:
Protocol Section:
NCT00561067