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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT03524651
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Age equal to or more than 18 years
* Written informed consent provided by the patient
* Hb below 10g/dl, as defined by other trials
* Absolute red blood cell (RBC) count below 4.5 x 106/mm3 for men or 4.0 x 106/mm3 for women
* Mean corpuscular volume (MCV) of RBCs below 80 fl
* Mean corpuscular Hb (MCH) of RBCs below 27 pg
* Total ferritin below 30 ng/ml; this criterion is associated with sensitivity more than 99% for iron deficiency
* In the case of patients with anemia after GI tract hemorrhage, inclusion criteria 6 and 7 DO NOT apply for study inclusion.
Exclusion Criteria:
* Age below 18 years
* Denial to provide written informed consent
* Acute myelogenous or lymphoblastic leukemia
* Multiple myeloma
* Primary or secondary myelodysplastic syndrome
* Planning for start of chemotherapy within the first 30 days after inclusion in the trial
* Planning for start of radiotherapy within the first 30 days after inclusion in the trial
* Intake of erythropoietin
* Planning for start of erythropoietin within the first 30 days after inclusion in the trial
* Intake of chemotherapy the last six months
* Intake of radiotherapy the last six months
* Known hemochromatosis
* Known celiac disease
* Liver cirrhosis of Child-Pugh stage II or III
* Any active overt bleeding
* Pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03524651
Study Brief:
Protocol Section:
NCT03524651