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NCT04349189 · ClinicalTrials.gov registry record
Venous Thrombosis Biomarkers in Sickle Cell Disease and Sickle Cell Trait
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 119
- Enrollment target
NCT04349189: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT04349189 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 119 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04349189 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 119 participants
- Enrollment target
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.
Primary Outcome
Number of tissue factor positive EVs/ml of plasma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2024-06-20 |
What the finished NCT04349189 record still lists
NCT04349189 is an observational study that tracks outcomes without assigning an intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04349189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04349189 about?
NCT04349189 is a clinical study titled "Venous Thrombosis Biomarkers in Sickle Cell Disease and Sickle Cell Trait". 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 ...
What is the current status of trial NCT04349189?
This trial is currently completed. The enrollment target is 119 participants. The study started on 2020-09-01. Estimated completion is 2024-06-20.
Who is sponsoring clinical trial NCT04349189?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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