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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT00236405
Eligibility Criteria:
Inclusion Criteria:
* Scheduled for primary unilateral knee arthroplasty with an expected discharge into an inpatient rehabilitation facility
* Hemoglobin \>11 to \<13 g/dL at screening and preoperative day -21
* Age 18 years or older
* Female subjects must be post-menopausal for at least one year or surgically sterile (hysterectomy or tubal ligation). Women of childbearing age must have negative pregnancy test(s) (serum HCG RIA at screening and urine at preoperative day -21, if applicable
* Preoperative lead time of at least 21 days
Exclusion Criteria:
* Medical conditions including: Known iron deficiency (defined as serum ferritin \<50 mg/l)
* chronic renal failure, significant hematological disease, uncontrolled hypertension, new onset seizures/uncontrolled seizures
* Expected to need another lower extremity major joint replacement within six months
* Undergoing cancer chemotherapy
* History of thrombotic vascular events including but not limited to stroke, transient ischemic attack, myocardial infarction and deep venous thrombosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00236405
Study Brief:
Protocol Section:
NCT00236405