Venous Thrombosis Biomarkers in Sickle Cell Disease and Sickle Cell Trait (NCT04349189) | Clinical Trial Compass
CompletedNot Applicable
Venous Thrombosis Biomarkers in Sickle Cell Disease and Sickle Cell Trait
United States119 participantsStarted 2020-09-01
Plain-language 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 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 hep…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
tissue factor positive
Timeframe: At baseline during study
Trial details
NCT IDNCT04349189
SponsorNational Heart, Lung, and Blood Institute (NHLBI)