Exhaled Carbon Monoxide as a Marker of Hemolysis in Sickle Cell Disease- an Exploratory Study
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|ClinicalTrials.gov Identifier: NCT01888614|
Recruitment Status : Withdrawn (Unable to secure equipment to proceed)
First Posted : June 28, 2013
Last Update Posted : December 23, 2016
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|Condition or disease|
|Sickle Cell Disease|
This is an observational study of sickle cell patients with the aim to measure exhaled carbon monoxide levels and to correlate with genotype and standard clinical markers of hemolysis.
Upon enrollment and at each subsequent visit, if acceptable to the patient, each subject will undergo measurement of exhaled carbon monoxide utilizing a hand held carbon monoxide monitor, MicroCO/Smoke check. Subsequent evaluations may be obtained during a routine visit, while hospitalized for a vasocclusive crises (VOC) episode, or when evaluated in the acute care clinic.
The principal study objective is to assess if exhaled carbon monoxide levels are a non-invasive marker of hemolysis in subjects with sickle cell disease (SCD).
The secondary study objective is to assess exhaled carbon monoxide levels serially in subjects with SCD, relative to vasocclusive crises, transfusion requirements, and pain syndromes.
The one inclusion criteria is for all adult sickle patients presenting for follow up at the outpatient sickle cell clinic who are capable of following simple instructions.
The exclusion criteria are a recent (2 week) history of lung infection, asthma, acute chest syndrome, or COPD exacerbation and/or a significant pulmonary dysfunction in the recent (3-6 month) past.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Exhaled Carbon Monoxide as a Marker of Hemolysis in Sickle Cell Disease- an Exploratory Study|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Sickle Cell Patients
Patients with Sickle Cell, over 18 years of age
- Exhaled Carbon Monoxide Level and hemolysis markers [ Time Frame: Participants will be followed for the duration of two years, at baseline clinically, or while hospitalized for a VOC episode, or when evaluated in the acute care clinic for pain or symptom exacerbation. ]Exhaled Carbon Monoxide Levels will be measured serially, at clinical baseline and with symptom exacerbation.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
All adult sickle patients presenting for follow up at the outpatient sickle cell clinic who are capable of following simple instructions.
A recent (2 week) history of lung infection, asthma, acute chest syndrome, or COPD exacerbation and/or a significant pulmonary dysfunction in the recent (3-6 month) past.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888614
|United States, Ohio|
|Seidman Cancer Center, University Hospitals|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Jane Little, MD||University Hospitals Cleveland Medical Center|
|Responsible Party:||Jane Little, Professor, University Hospitals Cleveland Medical Center|
|Other Study ID Numbers:||
|First Posted:||June 28, 2013 Key Record Dates|
|Last Update Posted:||December 23, 2016|
|Last Verified:||December 2016|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
carbon mono oxide
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn