Status:
COMPLETED
Venous Thrombosis Biomarkers in Sickle Cell Disease and Sickle Cell Trait
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sickle Cell Disease
Venous Thrombosis
Eligibility:
All Genders
18-80 years
Brief Summary
Background: Venous thromboembolism (VTE) includes the abnormal clotting of blood in a deep vein of the upper or lower limbs (deep vein thrombosis) that may travel to and block a blood vessel in the l...
Detailed Description
Venous thromboembolism (VTE) the third most frequent cause of vascular mortality after myocardial infarction and stroke, occurs more frequently among Americans of African descent compared with other e...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Sickle cell disease with and without VTE
- Sickle cell disease (HbSS, HbSC and HbS/beta-thalassemia genotypes) in steady state.
- Diagnosis of at least one or more VTE within 5 years of study enrolment confirmed by radiologic imaging (for SCD patients with VTE).
- Absence of clinical history of VTE (for SCD controls)
- Between 18 and 80 years of age.
- Ability to provide informed written consent.
- Sickle cell trait
- Sickle cell disease (HbAS genotype).
- Absence of clinical history of VTE
- Between 18 and 80 years of age.
- Ability to provide informed written consent.
- Ethnically matched controls
- Between 18 and 80 years of age.
- African, or of African descent.
- Ability to provide informed written consent.
- Absence of clinical history of VTE
- EXCLUSION CRITERIA:
- SCD with and without VTE
- Pregnancy (test done at enrollment; if a subject becomes pregnant during the study period, samples will not be obtained while the subject is pregnant and the subject will be taken off study).
- Patients on exchange transfusion or having received a simple blood transfusion in the past 60 days.
- 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. If the subject is positive for HCV Ab, a reverse transcriptasepolymerase chain reaction test will be conducted. Subjects with hepatitis C may be rescreened after receiving appropriate hepatitis C treatment.
- Testing positive for human immunodeficiency virus 1 or 2 Ab with evidence for ongoing active infection (i.e., CD 4 count \<400/microL and viral load \>100,000 copies/ml) on antiretroviral therapy.
- Active acute inflammatory disorders rheumatoid arthritis or systemic lupus erythematosus on disease modifying therapy.
- Diabetes mellitus judged to be under poor control by the Investigator evidenced by a single fasting sugar value \>250gm/dl or requiring \>3 antidiabetic agents, including insulin (all insulins are considered 1 agent); use of insulin per se is not exclusionary.
- SCT and ethnically matched controls
- Diagnosis of any of the following chronic disease or conditions: Sickle cell disease (HbSS, HbSC and HbS/beta-thalassemia genotypes).
- Clinical history of VTE.
- Pregnancy (test done at enrollment; if a subject becomes pregnant during the study period, samples will not be obtained while the subject is pregnant and the subject will be taken off study.
- 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. If the subject is positive for HCV Ab, a reverse transcriptasepolymerase chain reaction test will be conducted. Subjects with hepatitis C may be rescreened after receiving appropriate hepatitis C treatment.
- Testing positive for human immunodeficiency virus 1 or 2 Ab with evidence for ongoing active infection (i.e., CD 4 count \<400/microL and viral load \>100,000 copies/ml) on antiretroviral therapy.
- Active acute inflammatory disorders rheumatoid arthritis or systemic lupus erythematosus on disease modifying therapy.
- Diabetes mellitus judged to be under poor control by the Investigator evidenced by a single fasting sugar value \>250gm/dl or requiring \>3 antidiabetic agents, including insulin (all insulins are considered 1 agent); use of insulin per se is not exclusionary.
Exclusion
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 20 2024
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT04349189
Start Date
September 1 2020
End Date
June 20 2024
Last Update
August 1 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892