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 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT02918851
Eligibility Criteria:
Inclusion Criteria:
* Habitual exerciser defined as ≥ 30 minutes of at least moderate or high intensity exercise ≥ 3 times per week. After consent, and at the subsequent screening visit, a VO2 max test will be performed, and subjects with a low value (\< 35 mL/kg/min) will be excluded (screen failure). Based on our previous experience, we anticipate that \<10% of the subjects will fall into this category
* Calculated total blood volume (TBV) ≥4,500 mL using an established formula:
1. Men: (0.006012 x H3) + (14.6 x W) + 604 = TBV
2. Women: (0.005835 x H3) + (15 x W) + 183 = TBV \[H=height in inches; W=weight in pounds\]
* Has access to transportation to visit the blood collection facility and to return to Stony Brook for all study visits.
Exclusion Criteria:
* Any significant acute or chronic medical illness or problem, including, but not limited to, diabetes, hypertension, cardiac disease, asthma, chronic obstructive lung disease
* Current or recent (last 60 days) tobacco or nicotine use
* History of sickle cell trait or disease or any other acquired or hereditary hematological abnormality
* History of fainting or other significant adverse reaction during phlebotomy or donation of blood
* Known prolonged corrected QT interval (or evidence of such at screening) on electrocardiogram defined as \>470 ms
* Known or suspected illicit drug or alcohol abuse
* Known or suspected HIV, Hepatitis B, or Hepatitis C infection
* History of thrombophilia or anticoagulant therapy
* Pregnancy
* Obesity defined as BMI\>30
* Recent history of blood donation: a) Single whole blood unit donation within the past 8 weeks; b) Double RBC donation by apheresis within the past 16 weeks; or c) Plasma donation by apheresis within the past 4 weeks
* Inadequate RBC mass based on TBV \<4500 ml (above) or screening Hb \<14 g/dL
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02918851
Study Brief:
Protocol Section:
NCT02918851