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Carbon Dioxide for Sickle Cell Anemia

N/A
Recruiting
Led By Kristin P Guilliams, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hb SS or SBeta-thal
Not on vasodilatory medication, such as sildenafil or verapamil
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at how blood flow and metabolism affects brain development in early life. SCA participants and healthy controls will have their blood flow and metabolism examined using MRI, and will also undergo cognitive assessments and brief questionnaires.

Who is the study for?
This trial is for children and young adults aged 4-21 with sickle cell anemia (SCA) or healthy individuals without significant psychiatric history, epilepsy, stroke, or cerebrovascular disease. Participants must be able to have an MRI scan without sedation and not be pregnant.
What is being tested?
The study tests how breathing in carbon dioxide affects blood flow in the brain using MRI scans. It aims to understand blood vessel function related to oxygen delivery during normal activities and stress in SCA patients compared to healthy controls.
What are the potential side effects?
Breathing in controlled amounts of carbon dioxide may cause temporary discomfort such as a feeling of breathlessness or lightheadedness due to dilation of blood vessels but is generally well-tolerated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have sickle cell disease (Hb SS) or Sickle Beta-thalassemia.
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I am not taking any blood pressure-lowering medications like sildenafil or verapamil.
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I am between 4 and 21 years old.
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I have never had epilepsy.
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I can undergo an MRI scan without needing to be sedated.
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I am between 4 and 21 years old and healthy.
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I have never had a stroke or brain blood vessel issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Gray Matter cortical thickness
Secondary study objectives
Cerebrovascular Reactivity
Total Brain volume

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Sickle Cell AnemiaActive Control1 Intervention
Group II: Healthy ControlActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,740 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,378 Previous Clinical Trials
652,072 Total Patients Enrolled
Kristin P Guilliams, MDPrincipal InvestigatorWashington University School of Medicine

Media Library

Sickle Cell Anemia Clinical Trial Eligibility Overview. Trial Name: NCT04406818 — N/A
Sickle Cell Disease Research Study Groups: Sickle Cell Anemia, Healthy Control
Sickle Cell Disease Clinical Trial 2023: Sickle Cell Anemia Highlights & Side Effects. Trial Name: NCT04406818 — N/A
Sickle Cell Anemia 2023 Treatment Timeline for Medical Study. Trial Name: NCT04406818 — N/A
~34 spots leftby Mar 2026
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