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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Recruitment Status : Withdrawn (Unable to secure equipment to proceed)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
Sponsor:
Information provided by (Responsible Party):
Jane Little, University Hospitals Cleveland Medical Center

Study Description
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Brief Summary:
The investigators propose to evaluate etCO in patients with HbSS, HbSC, and HbS-beta thalassemia during routine clinic visits, and longitudinally. Our goal is to know whether etCO differs amongst subjects with different sickle cell syndrome genotypes, and whether it is a stable marker of hemolytic rate, as reflected in routine labs obtained for clinical care (including total hemoglobin, reticulocyte count, lactate dehydrogenase, and, when sampled, total and direct bilirubin). We hope to establish whether this inexpensive and non-invasive test faithfully reflects hemolytic parameters in sickle cell syndromes.

Condition or disease
Sickle Cell Disease

Detailed Description:

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 Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Sickle Cell Patients
Patients with Sickle Cell, over 18 years of age


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
Study Population
Adult sickle cell patients from hematology clinics at UHCMC Seidman Cancer Center would be recruited for serial measurements of exhaled CO levels, at baseline and during painful vaso-occlusive (VOC) episodes.
Criteria

Inclusion Criteria:

All adult sickle patients presenting for follow up at the outpatient sickle cell clinic who are capable of following simple instructions.

Exclusion Criteria:

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.

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Ohio
Seidman Cancer Center, University Hospitals
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Jane Little, MD University Hospitals Cleveland Medical Center
More Information
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Responsible Party: Jane Little, Professor, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01888614    
Other Study ID Numbers: 03-12-41
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
Keywords provided by Jane Little, University Hospitals Cleveland Medical Center:
carbon mono oxide
sickle cell
hemolysis
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Hemolysis
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Pathologic Processes