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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT03288233
Eligibility Criteria:
Inclusion Criteria:
* Subjects will be between age 18 and 75 years, non-pregnant, with a goal of equal gender and race (Caucasian vs. African-American) distribution
Exclusion Criteria:
* known hemoglobinopathy or RBC disorder
* positive pregnancy test (in women of child-bearing potential or are breast feeding or planning pregnancy during the course of the study;
* baseline serum creatinine \>1.5 mg/dl
* CBC outside the normal range
* history of GI blood loss or coagulopathy
* urine microalbumin \>100 mcg/mg creatinine (spot collection);
* transaminases \>3 X the upper limit of normal
* presence of serum antibodies to biotinylated proteins (which could interfere with the biotin RBC labeling protocol)
* greater than or equal to NYHA stage 3 heart failure;
* active infection;
* known rheumatologic disease
* uncontrolled hypo-or hyperthyroidism or an underlying illness known to be associated with either body wasting or changes in serum proteins
* lung transplantation, irradiation, recent surgery, recent intensive care admission, asthma, COPD, cystic fibrosis, smoking, recent hematoma, uncontrolled hypo- or hyperthyroidism or an underlying illness known to be associated with either body wasting or changes in serum proteins (e.g. certain malignancies including multiple myeloma or tuberculosis).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03288233
Study Brief:
Protocol Section:
NCT03288233