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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT01888003
Eligibility Criteria:
Inclusion Criteria:
1. 19 years to 80 years of age
2. American Society of Anesthesiologists 1-3 status
3. Undergoing total hip arthroplasty for osteoarthritis, (either a primary or replacement procedure, but not a revision procedure) OR avascular necrosis (AVN); OR undergoing total knee arthroplasty (replacement) for osteoarthritis
Exclusion Criteria:
1. American Society of Anesthesiologists 4 status
2. Severe anemia, defined as a hematocrit of \< 30%
3. History of hypercoagulability or thrombophilia (e.g, factor V Leiden)
4. History of deep venous thrombosis (DVT) or venous thromboembolism (VTE) within last 12 months
5. Current use of anticoagulants (e.g., heparin, warfarin, dabigatran, etc)
6. Diagnosis of chronic renal insufficiency requiring dialysis
7. Morbid obesity (BMI \> 40)
8. History of allergic reaction to intravenous iron
9. History of allergic reaction to an erythropoietic stimulating agent (ESA)
10. History of sickle cell disease
11. History of hemochromatosis
12. History of liver dysfunction or congestive heart failure
13. History of substance abuse disorder
14. History of major psychiatric disorder (e.g., major depression, bipolar disorder, axis II personality disorder, schizophrenia)
15. Uncontrolled hypertension (defined as a systolic pressure ≥ 160 mmHg and/or a diastolic pressure ≥ 110 mmHg)
16. History of uncontrolled cardiac arrhythmias, cerebrovascular accident (CVA), transient ischemic attack (TIA), acute coronary syndrome (ACS), or other arterial thrombosis. ACS includes unstable angina, Q wave myocardial infarction (QwMI), and non-Q wave myocardial infarction (NQMI) within 6 months
17. History of pure red cell aplasia (PRCA) after treatment with an ESA
18. History of seizure disorder
19. Any active/current cancer within the last 12 months (not including non-melanoma skin cancer)
20. Pregnancy or lactation
21. Non-native English speaker (because validated Spanish language versions of two of the patient questionnaires are not available)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT01888003
Study Brief:
Protocol Section:
NCT01888003