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NCT04406818 · ClinicalTrials.gov registry record · NA
Metabolic and Hemodynamic Reserve in Pediatric SCA
A NA study of Sickle Cell Disease and Anemia, Sickle Cell, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT04406818: Recruiting NA study of Sickle Cell Disease and Anemia, Sickle Cell, sponsored by Washington University School of Medicine.
NCT04406818 is a NA study of Sickle Cell Disease and Anemia, Sickle Cell that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 120 participants, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04406818, a NA study of Sickle Cell Disease and Anemia, Sickle Cell, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study 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. SCA participants and healthy controls are age and sex-matched for comparison. Within the SCA cohort, children with infarcts may have thinner cortices than those without, reflecting a greater loss. The investigators 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 may vary by age. The brain's blood flow changes in small ways during everyday activities, such exercise, deep concentration, or normal brain growth. 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 a full oxygen supply may cause the brain to grow and develop more slowly than when it has a full supply. 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, cognitive assessments, and brief questionnaires. The study team will use a special mask to control the amount of carbon dioxide the participants breathe in.
Primary Outcome
Mean whole brain cortical thickness on high resolution T1 images
Conditions Studied
Interventions
- DRUG Carbon Dioxide
Study Locations (1)
Missouri
- Washington University in St. Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2021-06-30 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
What NCT04406818 shows while recruiting
NCT04406818 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (59% lower).
The record links to 4 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which Carbon Dioxide is the first listed.
NCT04406818 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04406818 about?
NCT04406818 is a clinical study titled "Metabolic and Hemodynamic Reserve in Pediatric SCA". 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. SCA participants and healthy controls are age and sex-matched for comparison. Within the SCA cohort, children with infarcts may have thinner c...
What is the current status of trial NCT04406818?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2021-06-30. Estimated completion is 2026-03-31.
What conditions does trial NCT04406818 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Anemia, Sickle Cell, Brain Diseases, Child, Only.
What interventions are being tested in trial NCT04406818?
The interventions under investigation include: Carbon Dioxide (DRUG).
Who is sponsoring clinical trial NCT04406818?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04406818 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04406818's enrollment target sits among peer trials
120 51st of 213 higher than 159 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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