Non-Invasive Infrared Spectroscopy for Sickle Cell Disease

Overseen By Dianna Lovins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Must be taking: Hydroxyurea

Must not be taking: Oxbryta, Adakveo, Endari

Disqualifiers: Pregnancy, Mobility difficulties, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

49 Participants Needed

Trial Summary

What is the purpose of this trial?

Sickle cell disease (SCD) is an inherited disorder of the blood. SCD can injure the smallest blood vessels, which can cause pain and damage organs all over the body. Some treatments are available, but researchers need better ways to monitor the effects of these treatments. An imaging technique called near infrared spectroscopy (NIRS) may be helpful. Objective: To test NIRS as a tool for measuring oxygen levels, blood flow, and the makeup of skin and muscle in patients with SCD. Eligibility: People aged 18 years and older with SCD. Healthy volunteers are also needed as a comparison for the changes in SCD patients. Design: Participants will be screened. They will have a physical exam, and 1 teaspoon of blood will be drawn. Participants will have NIRS testing on their second visit. Probes will be placed on their skin. A blood pressure cuff will be placed on their arm. The cuff will be filled with air for up to 5 minutes and then released. Participants may be asked to breathe at a certain rate or hold their breath during these measurements. At this visit, participants will also have an ultrasound exam to get images of their heart. They will be monitored while they walk for 6 minutes. They will have 1 tablespoon of blood drawn. Their height, weight, and vital signs will be measured. Participants may be asked to return for up to 4 additional visits for NIRS testing within 120 days, but this is optional. The visits must be at least 3 days apart. Each visit will last up to an hour....

Research Team

Swee Lay Thein, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria

This trial is for adults with Sickle Cell Disease (SCD), including those on stable Hydroxyurea treatment. Healthy individuals are also needed for comparison. Pregnant women, people who can't walk for 6 minutes due to mobility issues, recent users of certain SCD medications, and those with specific surgical histories or blood transfusions are excluded.

Inclusion Criteria

I have been taking a consistent dose of Hydroxyurea for the last 90 days.

I am willing and able to give my consent for treatment.

I am 18 or older with an HbAA genotype.

Exclusion Criteria

I have not had a blood transfusion in the last 60 days or an exchange transfusion in the last 90 days.

Ethnically matched controls: Women who are currently pregnant

I have had a blood transfusion within the last 60 days or an exchange transfusion within the last 90 days.

Treatment Details

Interventions

• Near Infrared Spectroscopy (NIRS)

Trial Overview Researchers are testing Near Infrared Spectroscopy (NIRS) as a non-invasive method to measure muscle oxygen levels, blood flow, and tissue composition in patients with SCD compared to healthy controls. The study involves physical exams, NIRS tests during various activities, and up to five visits.

Participant Groups

Group I: 1 Experimental Treatment 1 Intervention

Single-arm study

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+