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Sickle Cell DiseaseNCT01547793

Carbon Monoxide Levels and Sickle Cell Disease Severity

An observational study of Sickle Cell Disease and Sickle Cell Anemia, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
106 participants
Where
1 siteUnited States
Study dates
26 Jan 2012to 4 Nov 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males or females 18 years of age or older
  • Diagnosis of sickle cell disease (any form; electrophoretic or HPLC documentation is required)
  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • Current pregnancy or lactation
  • Serum ALT values >80 IU/L
  • Serum creatinine >2.0 mg/dL
  • Hemoglobin <11.2 g/dL for females, <13.7 for males; however, subjects may return for repeat evaluation at a later date
  • Currently smoking
  • Subjects with any known form of sickle cell disease (sickle trait will NOT be excluded)
  • Subjects with any other known forms of hemolytic anemia

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: End-Alveolar Carbon Monoxide as a Measure of Erythrocyte Survival and Hemolytic Severity in Sickle Cell Disease

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.
Read more

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.
Read the detailed description

Sickle cell disease is an autosomal recessive disorder and the most common genetic disease affecting African-Americans. Approximately 0.15% of African-Americans are homozygous for sickle cell disease, and 8% have sickle cell trait. Hemoglobin S polymerization leads to red cell rigidity, microvascular obstruction, inflammation, and end-organ ischemic injury. Our published data indicate that up to 50% of sickle cell patients have vascular dysfunction due to impaired bioavailability of endogenous nitric oxide, due in large part to scavenging of nitric oxide by cell-free hemoglobin. In previous studies we have demonstrated that steady-state serum LDH is strongly associated with 1) other markers of intravascular hemolysis including plasma cell-free hemoglobin and arginase levels, 2) levels of soluble endothelial adhesion molecules, and 3) an impaired vasodilatory response to an NO donor. Further, significant steady-state LDH elevation identified a subset of patients in our cohort as well as the CSSCD cohort at increased risk for developing pulmonary hypertension, cutaneous leg ulceration, priapism, and early death. Previous biochemical studies have demonstrated significant transient increases in serum LDH and plasma hemoglobin levels during VOC, and this presumed hyperhemolysis has been confirmed by 51Cr labeled RBC studies that revealed further decreases in RBC survival during VOC. However, serum LDH levels are not a specific biomarker of hemolysis, and furthermore these observations on RBC survival have not been correlated with markers of intravascular hemolysis at baseline in patients with sickle cell disease in order to confirm the presence of chronic hyperhemolysis subphenotypes in sickle cell disease as posited in our previous work.

The current gold standards of random and cohort labeling of RBCs used to quantitate RBC survival suffer from many technical drawbacks that make them impractical for routine clinical use. The production rate of expired CO has previously been used to assess RBC survival, based upon the principal that virtually all CO produced in human beings results from cleavage of the ?-methene bond of heme and is completely excreted via the lungs. Because RBC destruction accounts for approximately 80% of heme turnover in the body, endogenous CO production can be used as a quantitative indicator of RBC life span. Furne et al have previously reported on the development of a simple, rapid, and noninvasive method for determining RBC life span based on measurement of exhaled alveolar CO concentration immediately upon awakening corrected for atmospheric CO, as determined with a device that simulates the body s equilibration with CO with results comparable to standard labeling techniques. We propose that this methodology could also provide a quantitative, simple, and noninvasive test to study the RBC life span and thus rate of hemolysis in those patients with sickle cell disease.

This trial will aim to 1) establish the use of end-alveolar CO concentration as a quantitative measure of RBC life span and hemolytic rate in subjects with sickle cell disease; 2) investigate the association between end-alveolar CO concentration-derived RBC life span and laboratory measures of hemolytic severity; and 3) investigate the association between end-alveolar CO concentration-derived RBC life span and the incidence of various clinical sequelae of sickle cell disease.

Keywords
Hemolytic Severity, Erythrocyte, Sickle Cell Disease, SD
Medical subject headings
Anemia, Sickle Cell

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2012 (estimated)
  2. Study start26 Jan 2012
  3. Study completion4 Nov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01547793
Sponsor's protocol ID
120069
Other IDs
12-H-0069
Status last verified
4 Nov 2015
First submitted
6 Mar 2012
Last updated
5 Apr 2019
Results posted
No

Publications

  • 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.

    PubMed 13218041
  • 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.

    PubMed 21264896
  • 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.

    PubMed 7993409
  • 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.

    PubMed 34000072

Questions about this trial

What is this clinical trial studying?

An observational study of Sickle Cell Disease and Sickle Cell Anemia, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01547793, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.

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