Exhaled Carbon Monoxide as a Marker of Hemolysis in Sickle Cell Disease- an Exploratory Study

• ClinicalTrials.gov Identifier: NCT01888614
• Recruitment Status: Withdrawn
• First Posted: June 28, 2013
• Last Update Posted: December 23, 2016
• Sponsor: University Hospitals Cleveland Medical Center
• Information provided by (Responsible Party): Jane Little, University Hospitals Cleveland Medical Center

Tracking Information

• First Submitted Date: June 19, 2013
• First Posted Date: June 28, 2013
• Last Update Posted Date: December 23, 2016
• Study Start Date: June 2013
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 21, 2016)

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.

Original Primary Outcome Measures (submitted: June 25, 2013)

• Exhaled Carbon Monoxide Level [ Time Frame: participants will be followed for the duration of two years, during their scheduled clinic visits (expected average of 24 visits) ]
  Exhaled Carbon Monoxide Levels will be measured at regular scheduled follow up visits.
• Exhaled Carbon Monoxide Level [ Time Frame: participants will be followed for the duration of two years during admission for sickle cell crisis ]
  Exhaled Carbon Monoxide Level will be measured during a hospital or FastTrack admission for sickle cell crisis, if such admission does occur.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Exhaled Carbon Monoxide as a Marker of Hemolysis in Sickle Cell Disease- an Exploratory Study
• Official Title: Exhaled Carbon Monoxide as a Marker of Hemolysis in Sickle Cell Disease- an Exploratory Study
• 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.

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 Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Sickle Cell Disease
• Intervention: Not Provided

Study Groups/Cohorts

Sickle Cell Patients

Patients with Sickle Cell, over 18 years of age

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: December 21, 2016): 0
• Original Estimated Enrollment (submitted: June 25, 2013): 50
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01888614
• Other Study ID Numbers: 03-12-41
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jane Little, University Hospitals Cleveland Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospitals Cleveland Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jane Little, MD; University Hospitals Cleveland Medical Center

• PRS Account: University Hospitals Cleveland Medical Center
• Verification Date: December 2016