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:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT00004759
Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Acute spinal cord injury; diagnosis confirmed by study physician using National Acute Spinal Cord Injury Study neurologic exam
Glasgow Coma Score greater than 9
Randomization within 6 hours of injury required; treatment must begin within 8 hours of injury
No root involvement only; no cauda equina only
--Prior/Concurrent Therapy--
Methylprednisolone bolus (20-40 mg/kg) prior to hospital admission allowed
--Patient Characteristics--
Hematopoietic: No hematologic contraindication to protocol therapy
Cardiovascular: No vascular contraindication to protocol therapy
Other: No diabetes; No gunshot wound; No gastrointestinal bleeding; No life-threatening co-morbidity; No other medical contraindication to protocol therapy; No pregnant women; No patients under indictment or incarcerated; No conditions that would complicate follow-up, e.g.: out-of-state residency or illegal alien status
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT00004759
Study Brief:
Protocol Section:
NCT00004759