Sickle Cell Anemia Clinical Trial
Official title:
Phase 1 Study of Carbon Monoxide Monitor for the Measurement of End-Tidal Carbon Monoxide Levels in Children With or Without Hemolysis
People who have Sickle Cell Anemia (HbSS) produce red blood cells with shorter lifespans. These red blood cells breakdown faster, and this is called hemolysis. When red blood cells breakdown, a tiny amount of Carbon Monoxide (CO) is released into the blood and is eliminated in exhaled breath. This research study will use a device called CoSense™, which will measure Carbon Monoxide (CO) levels in breath. The purpose of the study is to see how well the device measures the CO levels that an individual breathes out.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 5 Years to 14 Years |
Eligibility |
Inclusion Criteria: - Parental / legal guardian consent - Subject assent for participants ages 7 and above - Male and female children ages 5 - 14 years old - For Hb SS subjects, hemoglobin = 10 g/dL (based on a laboratory tests performed over the last 6 months and confirmed within 4 weeks prior to breath collection, as part of the subject's clinical care) Exclusion Criteria: - For healthy subjects, known to have the sickle cell trait - Had a red blood cell transfusion within 12 weeks prior to enrollment - Currently a primary smoker or was a primary smoker within 4 weeks prior to enrollment - Exposed to second hand smoke within 24 hours prior to breath sample collections - Have an upper respiratory infection within 2 weeks of ETCO measurements |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital & Research Center Oakland | Oakland | California |
Lead Sponsor | Collaborator |
---|---|
Ashutosh Lal |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | End-Tidal Carbon Monoxide Concentration | one year | No |
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