Comparing arterial function in children with sickle cell disease
The Relationship of Transcranial Doppler Velocity With Other Vascular Measurements in Children With Sickle Cell Anaemia
The University of The West Indies · NCT05748717
This study looks at how blood vessels work in children with sickle cell disease to see if there are differences between those with normal and abnormal blood flow measurements.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 34 (estimated) |
| Ages | 4 Years to 16 Years |
| Sex | All |
| Sponsor | The University of The West Indies (other) |
| Locations | 1 site (Kingston, Saint Andrew Parish) |
| Trial ID | NCT05748717 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess differences in arterial function parameters between children with sickle cell disease who have normal and abnormal transcranial Doppler velocity. Participants aged 4-16 will undergo various measurements, including vascular assessments and blood tests, to evaluate their arterial health. The study will compare those with normal Doppler results and no history of stroke to those with abnormal results, analyzing factors such as aortic pulse wave velocity and augmentation index. The goal is to identify significant differences that may inform future management of sickle cell disease.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 4-16 with sickle cell anemia who have undergone at least one complete transcranial Doppler study.
Not a fit: Patients who have had an erythrocyte transfusion in the past two months or are acutely ill may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of arterial health in children with sickle cell disease, potentially leading to improved monitoring and treatment strategies.
How similar studies have performed: While this approach is gaining recognition, similar studies have shown varying degrees of success in understanding arterial function in sickle cell disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pediatric participants with sickle cell anaemia (HbSS, HbSβ0 thalassemia, HbSD, HbSOArab) 2. Age: Between 4-16 years of age, at the time of enrolment 3. Has had at least one complete TCD study whether or not on hydroxyurea treatment or in a clinical trial. 4. Parent or guardian willing and able to provide informed consent and child gives assent 5. Ability to comply with study-related evaluations. Exclusion Criteria: * Participants who meet any of the following criteria are disqualified from enrollment in the study: 1. Patients in whom a TCD study cannot be completed 2. Patients who have had an Erythrocyte transfusion in the past two months 3. Patients who are acutely ill or have had an acute infection in the past two weeks
Where this trial is running
Kingston, Saint Andrew Parish
- Caribbean Institute for Health Research, The University of the West Indies — Kingston, Saint Andrew Parish, Jamaica (RECRUITING)
Study contacts
- Study coordinator: Angela E Rankine-Mullings, MB;BS
- Email: angela.rankinemullings@uwimina.edu.jm
- Phone: 8768545374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sickle Cell Disease, Sickle Cell disease, Transcranial Doppler Velocity, Arterial Stiffness, Augmentation Index, Arterial Function