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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

Study 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.Check my eligibility
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.See study design
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 sometimes have headaches but don't take daily medication for them.
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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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gray Matter cortical thickness
Secondary outcome measures
Cerebrovascular Reactivity
Total Brain volume

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
1,928 Previous Clinical Trials
2,296,844 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,337 Previous Clinical Trials
648,724 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate enrollment rate for this experiment?

"Affirmative. Records from the clinicaltrials.gov website show that this particular trial, initially posted on June 15th 2021, is actively looking for participants. 120 individuals need to be enrolled at 1 location."

Answered by AI

Is enrollment for this research project currently available?

"According to the listings on clinicaltrials.gov, this study is still in need of participants; it was published on June 15th 2021 and its specifications were most recently updated on March 27th 2022."

Answered by AI

May I participate in this clinical experiment?

"This clinical study is open to 120 candidates aged between 4 and 21, suffering from a range of neurological conditions. To qualify for enrolment, potential participants must not have experienced epileptic seizures in the past; be on any vasodilatory medication such as sildenafil or verapamil; nor should they currently pregnant or take regular preventative medications for headaches. Additionally, those with significant psychiatric diagnoses, history of strokes/cerebrovascular diseases may not partake either."

Answered by AI

How is Sickle Cell Anemia traditionally treated?

"Sickle cell anemia is a therapeutic agent used to address post-operative respiration, stapedectomy, endoscopy and Hypoplastic Left Heart Syndrome."

Answered by AI

Does this trial have any age-related restrictions for potential participants?

"Those under the age of 21 and over 4 years old can be included in this trial. Data from clinicaltrials.gov indicates that there are 314 trials for minors, and 328 specifically for patients aged 65 or older."

Answered by AI
~51 spots leftby Mar 2026