Sickle Cell DiseaseCOMICNCT04157179
Cerebral Oxygen Metabolism in Children
A study testing Carbon Dioxide in people with Sickle Cell Disease and Cerebral Stroke, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to better understand how blood flow and metabolism change can influence brain development in the early decades of life. We will examine brain blood flow and metabolism using magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 3 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease, Cerebral Stroke
- What is being tested?
- Carbon Dioxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2019to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Healthy Controls:
- Healthy controls ages 3-50 years of age
- Able to participate in MRI scan without sedation
- Not currently pregnant
- No significant psychiatric history, defined as having a severe psychiatric diagnosis, per PI discretion
- No history of epilepsy
- No history of stroke or cerebrovascular disease
- May have occasional headaches if not taking a daily preventative medication for headaches
- Not on vasodilatory medication, such as sildenafil or verapamil
Sickle Cell Anemia Participants:
- Ages 3-50 years of age
- Hb SS or SBeta-thal
- Able to participate in MRI scan without sedation
- Not currently pregnant
- Not on vasodilatory medication, such as sildenafil or verapamil
Extracorporeal Membrane Oxygenation (ECMO) Survivors:
- Ages 3-50 years of age
- History of cannulation for ECMO
- Able to participate in MRI scan without sedation
- Not currently pregnant
- Not on vasodilatory medication, such as sildenafil or verapamil
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University of St. Louis
St Louis, Missouri, 63110
Kristin Guilliams, MD, 3144546120, kristinguilliams@wustl.edu
About this study
The purpose of this research study is to better understand how blood flow and metabolism change can influence brain development in the early decades of life.
We will examine brain blood flow and metabolism using magnetic resonance imaging (MRI). The brain's blood vessels expand and constrict to regulate blood flow based on the brain's needs. The amount of expanding and contracting the blood vessels can do varies by age. The brain's blood flow changes in small ways during everyday activities, such as normal brain growth, exercise, or deep concentration. Significant illness or psychological stress may increase the brain's metabolic demand or cause other bigger changes in blood flow. If blood vessels are not able to expand to give more blood flow when metabolic demand is high, the brain may not get all of the oxygen it needs. In extreme circumstances, if the brain is unable to get enough oxygen for a long time, a stroke may occur. Sometimes small strokes occur without other noticeable changes and are only detectable on an MRI. These are sometimes called "silent strokes." In less extreme circumstances, not having as much oxygen as it wants may cause the brain to grow and develop more slowly than it should.
Read more
One way to test the ability of blood vessels to expand is by measuring blood flow while breathing in carbon dioxide. Carbon dioxide causes blood vessels in the brain to dilate without increasing brain metabolism.
During this study participants may be asked to undergo a blood draw, MRI, and potential neuropsychological assessments. It is also possible that the study team will use a special mask to control the amount of carbon dioxide the participants breathe in so they don't breathe in too much.
Read the detailed description
The purpose of the study is to identify imaging biomarkers for brain tissue under high metabolic stress at risk for permanent injury. We will measure CBF, OEF, and CVR in children with and without perturbations in cerebral oxygen delivery over time to determine each parameter's role in clinical and radiologic neurologic outcomes. Measuring CBF and OEF can be done with specialized MRI sequences. Measuring CVR requires a vasoactive response, such as carbon dioxide. In order to delivery carbon dioxide evenly and as safely as possible, we will use an MRI-compatible device to prevent over-breathing carbon dioxide and allow rapid steady-state physiology to minimize total scan time.
- Conditions
- Sickle Cell Disease, Cerebral Stroke
- Being tested
- Carbon Dioxide
- Keywords
- extracorporeal membrane oxygenation, cerebrovascular reactivity, sickle cell disease, healthy controls, magnetic resonance imaging
- Medical subject headings
- Anemia, Sickle Cell, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon DioxideOther
Participants inhale carbon dioxide while in magnetic resonance imaging scan to measure cerebrovascular reactivity
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Active comparator | Not described Receives: Other: Carbon Dioxide |
| Extracorporeal Membrane Oxygenation survivors | Active comparator | Not described Receives: Other: Carbon Dioxide |
| Sickle Cell Anemia participants | Active comparator | Not described Receives: Other: Carbon Dioxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Oxygen Metabolism
Measured: From the beginning of the MRI scan to the completion of the MRI scan -- 75 minutes.
Secondary outcomes (1)
Cerebrovascular Reactivity
Measured: From administration of carbon dioxide to end of inhalation of carbon dioxide -- 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start17 Oct 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All arms will receive the same study conditions.
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157179
- Sponsor's protocol ID
- 201905044
- Acronym
- COMIC
- Status last verified
- Sep 2025
- First submitted
- 6 Nov 2019
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygen Metabolism in Children
- ClinicalTrials.gov ID
- NCT04157179
- Acronym / sponsor ID
- COMIC / 201905044
- Conditions
- Sickle Cell Disease, Cerebral Stroke
- Keywords
- extracorporeal membrane oxygenation, cerebrovascular reactivity, sickle cell disease, healthy controls, magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to better understand how blood flow and metabolism change can influence brain development in the early decades of life.
We will examine brain blood flow and metabolism using magnetic resonance imaging (MRI). The brain's blood vessels expand and constrict to regulate blood flow based on the brain's needs. The amount of expanding and contracting the blood vessels can do varies by age. The brain's blood flow changes in small ways during everyday activities, such as normal brain growth, exercise, or deep concentration. Significant illness or psychological stress may increase the brain's metabolic demand or cause other bigger changes in blood flow. If blood vessels are not able to expand to give more blood flow when metabolic demand is high, the brain may not get all of the oxygen it needs. In extreme circumstances, if the brain is unable to get enough oxygen for a long time, a stroke may occur. Sometimes small strokes occur without other noticeable changes and are only detectable on an MRI. These are sometimes called "silent strokes." In less extreme circumstances, not having as much oxygen as it wants may cause the brain to grow and develop more slowly than it should.
One way to test the ability of blood vessels to expand is by measuring blood flow while breathing in carbon dioxide. Carbon dioxide causes blood vessels in the brain to dilate without increasing brain metabolism.
During this study participants may be asked to undergo a blood draw, MRI, and potential neuropsychological assessments. It is also possible that the study team will use a special mask to control the amount of carbon dioxide the participants breathe in so they don't breathe in too much.
Detailed description
The purpose of the study is to identify imaging biomarkers for brain tissue under high metabolic stress at risk for permanent injury. We will measure CBF, OEF, and CVR in children with and without perturbations in cerebral oxygen delivery over time to determine each parameter's role in clinical and radiologic neurologic outcomes. Measuring CBF and OEF can be done with specialized MRI sequences. Measuring CVR requires a vasoactive response, such as carbon dioxide. In order to delivery carbon dioxide evenly and as safely as possible, we will use an MRI-compatible device to prevent over-breathing carbon dioxide and allow rapid steady-state physiology to minimize total scan time.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All arms will receive the same study conditions.
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Active comparator | Other: Carbon Dioxide |
| Extracorporeal Membrane Oxygenation survivors | Active comparator | Other: Carbon Dioxide |
| Sickle Cell Anemia participants | Active comparator | Other: Carbon Dioxide |
Who may qualify
- Ages
- 3 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon DioxideParticipants inhale carbon dioxide while in magnetic resonance imaging scan to measure cerebrovascular reactivity | Other | Extracorporeal Membrane Oxygenation survivors, Healthy Controls, Sickle Cell Anemia participants |
Primary outcome
Cerebral Oxygen Metabolism
Time frame: From the beginning of the MRI scan to the completion of the MRI scan -- 75 minutes.
1 secondary outcome
Cerebrovascular Reactivity
Time frame: From administration of carbon dioxide to end of inhalation of carbon dioxide -- 15 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon Dioxide in people with Sickle Cell Disease and Cerebral Stroke, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin Guilliams, MD (3144546120, kristinguilliams@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Oxygen Metabolism (time frame: From the beginning of the MRI scan to the completion of the MRI scan -- 75 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.