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Venous Thrombosis Biomarkers in Sickle Cell Disease and Sickle Cell Trait

NCT04349189 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 119

Last updated 2025-08-01

No results posted yet for this study

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.

Conditions

  • Sickle Cell Disease
  • Venous Thrombosis
  • Sickle Cell Trait
  • Hypercoagulable State
  • Venous Thromboembolism

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

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

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2024-06-20
Completion
2024-06-20

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04349189 on ClinicalTrials.gov