NCT04349189Completed

Venous Thrombosis Biomarkers in Sickle Cell Disease and Sickle Cell Trait

Source: ClinicalTrials.gov · Last updated 12 Jun 2026

Brief summary (registry, in English)

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 lung (pulmonary embolism). Some people with sickle cell disease (SCD)-a red blood cell disorder-seem to be at greater risk for developing these blood clots. Researchers want to study the blood of people with SCD and VTE as well as healthy people to develop better treatments to prevent blood clots. Objective: To study blood clotting in SCD because it is the most common cause of vascular death after a heart attack or stroke. Eligibility: People ages 18-80 who have SCD (with or without a history of blood clots) or the trait for SCD, and healthy volunteers Design: Participants will be screened with medical history, physical exam, and medical records review. They will give blood samples. Participants will have phone calls either every 3 months or once a year, for 2 years. They will give updates on their health. They may give additional medical records. The phone calls may last up to 30 minutes. If participants have a VTE or pain crisis episode, they may visit the Clinical Center. These visits may last up to 4 hours. They will repeat the screening tests and give blood samples. Some participants may be invited to take part in blood studies. After 2 years, some participants will have a follow-up visit at the Clinical Center. Participation will last for about 2 years.

Status (registry): Completed
Study type: Observational
Enrollment: 119 (actual)
First submitted: 15 Apr 2020
Start date: 1 Sept 2020
Primary completion date: 20 Jun 2024
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Diseases: Sickle cell disease
NCT number: NCT04349189

What you commit to

Study type: Observational
Participants enrolled: 119
From 1 Sept 2020 to the primary completion date, 20 Jun 2024
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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.
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.

Other illness

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.
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.

Lab values

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.
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.

Other

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).
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.

Criteria the registry did not label

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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Institutes of Health Clinical Center Coordinator of this site? Confirm its status	Bethesda	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.