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 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT00706667
Eligibility Criteria:
Inclusion Criteria:
* \> 18 years of age and signed written informed consent
* Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery)
* 10 g/dl \< Hb \< 13.0 g/dl for men and 10 g/dl \< Hb \< 12.0 g/dl for women, at screening ( 3 weeks prior to surgery)
* Ferritin \< 100 μg/l or 100-300 with TSat \< 20%
Exclusion Criteria:
* Suspicion of iron overload (Ferritin \>300 μg/l or/and TSAT\>50%)
* Active severe infection/inflammation (defined as serum CRP \> 20 mg/l) or diagnosed malignancy
* Folate-and/or Vitamin B12 deficiency (according to local lab reference range)
* Known history of hepatitis B/C or HIV-positive
* Liver values 3 times higher than normal
* Immunosuppressive or myelosuppressive therapy
* A concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients.
* Pregnancy or lactation
* Transfusion within 1 month prior to study inclusion, EPO treatment with in the last 4 weeks, any iron treatment within 4 weeks prior to the inclusion in the trail
* Participation in any other therapeutic trial within the previous month
* History of thromboembolic events in the family or the patient
* Severe peripheral, coronary or carotid artery disease
* Bodyweight \< 50 kg
* Patients not able to understand the German language
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00706667
Study Brief:
Protocol Section:
NCT00706667