Venous Thrombosis Biomarkers in SCD and SCT

About the study

To study blood clotting in SCD because it is the most common cause of vascular death after a heart attack or stroke.

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Study point of contact

James Nichols, RN
(301) 755-7432
jnichols@mail.nih.gov

Locations

1 United States site

Genotypes

All SCD, SCT

Study type

Observational

Compensation

Unknown

participation requirements

Individuals with sickle cell disease with and without Venous thromboembolism (VTE) should enroll if they:

  • Have sickle cell disease (HbSS, HbSC and HbS/beta-thalassemia genotypes) in steady state
  • Have a diagnosis of at least one or more VTE within 5 years of study enrollment confirmed by radiologic imaging (for SCD patients with VTE)
  • Do not have a clinical history of VTE (for SCD controls)

Individuals with sickle cell trait

  • Sickle cell trait (HbAS genotype)
  • Do not have a of clinical history of VTE

Ethnically matched controls

  • Between 18 and 80 years of age
  • African, or of African descent
  • Ability to provide informed written consent
  • Do not have a clinical history of VTE

participation restrictions

Individuals with sickle cell disease, do not enroll if you:

  • Are pregnant or may become pregnant
  • Are on exchange transfusion or having received a simple blood transfusion in the past 60 days.
  • Have an active viral infection as evidenced by testing positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody (Ab) with signs of active hepatitis B or C virus infection
  • Test positive for human immunodeficiency virus 1 or 2 Ab with evidence for ongoing active infection
  • Have an active acute inflammatory disorders: rheumatoid arthritis or systemic lupus erythematosus on disease modifying therapy
  • Have diabetes mellitus (judged to be under poor control by the Investigator) – use of insulin per se does not exclude you

Individuals with SCT and ethnically matched controls

  • Are diagnosed with sickle cell disease (HbSS, HbSC and HbS/beta-thalassemia genotypes)
  • Have a clinical history of VTE
  • Are pregnant or may become pregnant
  • Have an active viral infection as evidenced by testing positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody (Ab) with signs of active hepatitis B or C virus infection.
  • Test positive for human immunodeficiency virus 1 or 2 Ab with evidence for ongoing active infection
  • Have an active acute inflammatory disorders: rheumatoid arthritis or systemic lupus erythematosus on disease modifying therapy
  • Have diabetes mellitus (judged to be under poor control by the Investigator) – use of insulin per se does not exclude you

Locations

  • Memphis, TN, United States

More info

VIEW ON CLINICALTRIALS.GOV
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Last updated April 30, 2022
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