Venous Thrombosis Biomarkers in SCD and SCT

Study point of contact

James Nichols, RN
(301) 755-7432
[email protected]

Locations

1 United States site

Genotypes

All SCD, SCT

Study type

Observational

Compensation

Unknown

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 requirements

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)

Sickle cell trait

  • Sickle cell disease (HbAS genotype).
  • Absence 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.
  • Absence of clinical history of VTE

participation restrictions

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.

Locations

  • Memphis, United States

More info

View on ClinicalTrials.gov
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