Status:
COMPLETED
Carbon Monoxide Monitor for the Measurement of End-Tidal Carbon Monoxide Levels in Children With or Without Hemolysis
Lead Sponsor:
Ashutosh Lal
Conditions:
Sickle Cell Anemia
Eligibility:
All Genders
5-14 years
Phase:
NA
Brief Summary
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 a...
Detailed Description
Subjects diagnosed with homozygous sickle cell anemia (Hb SS) have red blood cells with a decreased lifespan, which leads to an increase in the rate of heme turnover. Carbon monoxide (CO) is a by-prod...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01848691
Start Date
October 1 2012
End Date
March 1 2014
Last Update
June 2 2014
Active Locations (1)
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1
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609