Carbon Monoxide Levels and Sickle Cell Disease Severity

NCT01547793 | Completed

• 2 other identifiers: 12006912-H-0069
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Some people with sickle cell disease have different health problems than others. This may be related to how easily and frequently the red blood cells break apart in the blood. Researchers want to test breath and blood samples from people with sickle cell disease to look for very small amounts of carbon monoxide, which is produced when red blood cells break apart. They will compare these results with breath samples from healthy volunteers. Studying different levels of carbon monoxide may help predict what health problems a person with sickle cell disease may get. It may also provide more information on possible treatments. Objectives: \- To study breath carbon monoxide levels and their possible relation to the severity of sickle cell disease. Eligibility:

• Individuals at least 18 years of age with sickle cell disease.
• Healthy volunteers who are matched for age, sex, and race with the sickle cell disease group. Design:
• Participants will be screened with a medical history.
• Participants with sickle cell disease will provide a blood sample and have a heart function test. They will also breathe into a bag to provide an exhaled breath sample.
• Healthy volunteers will provide an exhaled breath sample.
• No treatment or care will be provided as part of this study.

Conditions

Sickle Cell Disease; Sickle Cell Anemia; Anemia, Sickle Cell

Keywords

Hemolytic Severity; Erythrocyte; Sickle Cell Disease; SD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Males or females 18 years of age or older
• Diagnosis of sickle cell disease (any form; electrophoretic or HPLC documentation is required)
• Chronic scheduled transfusions
• Current known pregnancy or lactation
• Hemoglobin \<5.0 g/dL; however, subjects may return for repeat evaluation at a later date
• Currently smoking and unable to refrain from smoking for 24 hours
• Subjects previously known to have conditions that may independently affect hemolytic rate:
• Infection or sepsis in the 2 weeks prior to screening
• Autoimmune hemolytic anemia
• Systemic lupus erythematosus (SLE)
• Myelodysplastic disorders, leukemia, or lymphoma
• Hereditary spherocytosis or elliptocytosis
• Severe cardiac valve dysfunction (e.g. AS, MS) or prosthetic heart valve recipients
• In order to validate the methodology for endogenous CO measurement, initially for each enrolled study subject with sickle cell disease (up to the first 30 subjects), we will recruit an African-American healthy control subject of the same gender, within 3 years of age older or younger than the matched subject with SCD. Additionally, 20 healthy control subjects will be enrolled for adenosine and any functionally or chemically related molecules blood testing, and venous blood gas testing only, to compare against subjects with sickle cell disease. Their participation in this study will consist of one blood draw of 11 mL for research laboratory testing.
• Current pregnancy or lactation

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• CROSBY WH. The metabolism of hemoglobin and bile pigment in hemolytic disease. Am J Med. 1955 Jan;18(1):112-22. doi: 10.1016/0002-9343(55)90208-4. No abstract available.

  PMID: 13218041 BACKGROUND

• Hebbel RP. Reconstructing sickle cell disease: a data-based analysis of the "hyperhemolysis paradigm" for pulmonary hypertension from the perspective of evidence-based medicine. Am J Hematol. 2011 Feb;86(2):123-54. doi: 10.1002/ajh.21952.

  PMID: 21264896 BACKGROUND

• Platt OS, Brambilla DJ, Rosse WF, Milner PF, Castro O, Steinberg MH, Klug PP. Mortality in sickle cell disease. Life expectancy and risk factors for early death. N Engl J Med. 1994 Jun 9;330(23):1639-44. doi: 10.1056/NEJM199406093302303.

  PMID: 7993409 BACKGROUND

• van Vuren AJ, Minniti CP, Mendelsohn L, Baird JH, Kato GJ, van Beers EJ. Lactate dehydrogenase to carboxyhemoglobin ratio as a biomarker of heme release to heme processing is associated with higher tricuspid regurgitant jet velocity and early death in sickle cell disease. Am J Hematol. 2021 Sep 1;96(9):E315-E318. doi: 10.1002/ajh.26243. Epub 2021 Jun 10. No abstract available.

  PMID: 34000072 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

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

Study Officials

• John F Tisdale, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 8, 2012
• Study Start: January 26, 2012
• Study Completion: November 4, 2015
• Last Updated: April 5, 2019

Record last verified: 2015-11-04

Locations

US (1)