Scientists hunt for clot clues in sickle cell blood
NCT ID NCT04349189
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study examined blood samples from 119 adults with sickle cell disease, sickle cell trait, or no condition to understand why some develop dangerous blood clots. Participants gave blood and had health check-ins over two years. The goal was to find biomarkers that could lead to better prevention of clots.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could point toward better ways to predict and prevent blood clots in people with sickle cell disease.
- What could go wrong
- This is an observational study, not a treatment trial. It may not directly lead to new therapies, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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119 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Jun 2024
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The natural history of SCD 04-H-0161 protocol (NCT00081523) will specifically be leveraged to recruit participants with VTE. In this study we will assess feasibility of establishing a prospective natural history study of thrombosis in SCD. Establishing feasibility could lead to recruitment of SCD patients experiencing thrombosis, particularly those that are understudied including patients with HbSC disease.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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