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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT00559494
Eligibility Criteria:
Inclusion Criteria:
* Age 16 or over
* Motor complete or motor incomplete acute spinal cord injury involving bony spinal levels between C0 and T11
* Patient able to provide informed consent
* Randomization and commencement of administration of first drug dose within 12 hours of injury
* surgical decompression if needed to be performed within 24 hours of the injury
* subjects exhibiting spinal cord perfusion pressure (lumbar drain transduced pressure - mean arterial pressure)\> 75 mmHg will be randomized to active augmentation protocol versus maintenance of mean arterial pressure
Exclusion Criteria:
* Acute spinal cord injury \>12 hours old
* Isolated sensory deficit, motor intact
* Isolated cauda equina injury or injury at bony level T12 or below
* History of systemic lupus erythematosus (SLE)
* Pre-existing hepatic or renal disease
* Tetracycline hypersensitivity
* Pregnancy or breast feeding
* Isolated sensory deficit
* Isolated radicular motor deficit
* Significant leukopenia (white blood cell count \< ½ times the lower limit of normal) at screening
* Elevated liver function tests (AST, ALT, alkaline phosphatase, or total bilirubin \> 2 times the upper limit of normal) at screening
* Presence of systemic disease that might interfere with patient safety, compliance or evaluation of the condition under study (e.g. insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, HIV, HTLV-1)
* Associated traumatic conditions interfering with informed consent or outcome assessment (e.g. closed head injury, liver contusion)
* Known uncorrected severe coronary artery disease or evidence of active coronary ischemia (ECG changes, positive Troponin) will be excluded from SCPP randomization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00559494
Study Brief:
Protocol Section:
NCT00559494