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

NCT01888614 | Withdrawn

• 1 other identifier: 03-12-41
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

carbon mono oxide; sickle cell; hemolysis

Outcome Measures

Primary Outcomes (1)

• Exhaled Carbon Monoxide Level and hemolysis markers

  Exhaled Carbon Monoxide Levels will be measured serially, at clinical baseline and with symptom exacerbation.

  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.

Study Arms (1)

Sickle Cell Patients

Patients with Sickle Cell, over 18 years of age

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

Seidman Cancer Center, University Hospitals

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Hemolysis

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jane Little, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 28, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 23, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)