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Protocol Details

Venous Thrombosis Biomarkers in Sickle Cell Disease and Sickle Cell Trait

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-H-0068

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 80

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women and Fetuses;
Children

Special Instructions

Currently Not Provided

Keywords

hypercoagulable state;
Recurrence;
Biomarkers;
Venous Thromboembolism;
Vascular Mortality

Recruitment Keyword(s)

None

Condition(s)

Sickle Cell Disease;
Venous Thrombosis;
Sickle Cell Trait;
hypercoagulable state;
venous thromboembolism

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Heart, Lung, and Blood Institute

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.

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Eligibility

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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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Arun S. Shet, M.D.
National Heart, Lung and Blood Institute (NHLBI)



James Nichols, R.N.
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 5-5140
10 Center Drive
Bethesda, Maryland 20892
(301) 755-7432
jnichols@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT04349189

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