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 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT00656292
Eligibility Criteria:
Inclusion Criteria:
1\. Patients scheduled for elective major spine surgery (multilevel (2-6 level) open thoracic or lumbar spine surgery with instrumentation)
Exclusion Criteria:
1. Pregnancy
2. Lactating females
3. Oral or parenteral corticosteroid use in the past 30 days
4. Elevation of AST or ALT \> 3x normal
5. Elevation of creatinine kinase \> 2x normal
6. Previous adverse drug reaction to any medication in the statin class
7. Current use of fibrates, niacin, itraconazole, ketoconazole, macrolide antibiotics, HIV protease inhibitors and/or nefazodone
8. Active liver disease
9. Current statin use
10. Anti-inflammatory use of the following medications within the last 30 days:
* Sulfasalazine
* Mycophenolate
* Cyclosporine
* Cyclophosphamide
* Azathioprine
* Chlorambucil
* Minocycline
* Myochrysine
* Penicillamine
* Hydroxychloroquine
* Leflunomide
11. Any medications listed in 3 or 10 above in the post-operative period
12. Use of Activated protein C at any time during the patients hospitalization
13. Use of anti-inflammatory medications listed below within the last 30 days:
* Leflunomide
* Sulfasalazine
* Mycophenolate
* Cyclosporine
* Cyclophosphamide
* Azathioprine
* Chlorambucil
* Minocycline
* Myochrysine
* Penicillamine
* Hydroxychloroquine
* Methotrexate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00656292
Study Brief:
Protocol Section:
NCT00656292