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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT01547793
Eligibility Criteria:
* ELIGIBILITY CRITERIA:
All volunteer subjects must be at least 18 years of age and have provided informed, written consent for participation in this study. Eligibility in the study is determined prior to enrollment on the basis of the following inclusion and exclusion criteria. Laboratory values obtained within the preceding 60 days are sufficient for screening purposes.
INCLUSION CRITERIA for SCD Cohort
Males or females 18 years of age or older
Diagnosis of sickle cell disease (any form; electrophoretic or HPLC documentation is required)
EXCLUSION CRITERIA for SCD Cohort
Chronic scheduled transfusions
Current known pregnancy or lactation
Hemoglobin \<5.0 g/dL; however, subjects may return for repeat evaluation at a later date
Currently smoking and unable to refrain from smoking for 24 hours
Subjects previously known to have conditions that may independently affect hemolytic rate:
* Infection or sepsis in the 2 weeks prior to screening
* Autoimmune hemolytic anemia
* Systemic lupus erythematosus (SLE)
* Myelodysplastic disorders, leukemia, or lymphoma
* Hereditary spherocytosis or elliptocytosis
* Severe cardiac valve dysfunction (e.g. AS, MS) or prosthetic heart valve recipients
INCLUSION CRITERIA for Controls
In order to validate the methodology for endogenous CO measurement, initially for each enrolled study subject with sickle cell disease (up to the first 30 subjects), we will recruit an African-American healthy control subject of the same gender, within 3 years of age older or younger than the matched subject with SCD. Additionally, 20 healthy control subjects will be enrolled for adenosine and any functionally or chemically related molecules blood testing, and venous blood gas testing only, to compare against subjects with sickle cell disease. Their participation in this study will consist of one blood draw of 11 mL for research laboratory testing.
EXCLUSION CRITERIA for Controls
Current pregnancy or lactation
Serum ALT values \>80 IU/L
Serum creatinine \>2.0 mg/dL
Hemoglobin \<11.2 g/dL for females, \<13.7 for males; however, subjects may return for repeat evaluation at a later date
Currently smoking
Subjects with any known form of sickle cell disease (sickle trait will NOT be excluded)
Subjects with any other known forms of hemolytic anemia
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01547793
Study Brief:
Protocol Section:
NCT01547793