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.
Participation information
Locations
1 United States site
Gender
Male
Genotypes
Hb SS
Hb SC
Study Information
Study type
Survey
Compensation
No
Am I Eligible
Requirements
You may be eligible to participate in this study if you: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
Restrictions
You can't participate in this study if you: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
Study point of contact
| James Nichols, RN | |
| (301) 755-7432 | |
| jnichols@mail.nih.gov |
Locations
- Memphis, TN, United States