Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04800809 |
| Other study ID # |
191560 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2020 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
Vanderbilt University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Sickle Cell Anemia (SCA) occurs in 300,000 newborns per year in the world, with 150,000
affected births in Nigeria, alone. With improvement in survival for children with SCA in both
high- and low-resource countries, neurological morbidity is an emerging significant public
health challenge, particularly in countries with a high rate of sickle cell disease (SCD).
Both silent cerebral infarcts (SCI) and overt strokes result in significant neurological
morbidity and premature death. Five NIH-funded randomized controlled trials (RCT)
demonstrated that regular blood transfusion or hydroxyurea therapy are efficacious treatments
for primary and secondary stroke prevention in children with SCA. Despite the observation
that at least 99% of children with SCA in high-resource settings reach adulthood, and
approximately 60% of adults will experience one or more strokes (~50% with SCI and ~10% with
overt strokes) and the high disease-burden in Nigeria, the prevalence and incidence rates of
new and recurrent stroke (overt and silent strokes)have not been collected systematically in
children and young adults (16-25 years old) with SCA. In the last decade, there has been
growing use of stroke registries in economically advanced nations, particularly for
epidemiological purposes of trend analysis, clinical effectiveness, compliance to guidelines,
assessment of implementation, adoption of novel techniques, and quality improvement process.
For the first time in clinical centers in Nigeria, the Investigators will conduct an
observational epidemiological study to document the prevalence and track the incidence of new
and recurrent strokes in children and young adults with SCD. The Investigators will create a
stroke registry referred to as the Afolabi Stroke Registry for Children and Young Adults with
Sickle Cell Disease in Nigeria. The overall purpose of the stroke registry is to document the
natural history of SCD in a low-resource setting and to improve the quality of the care of
children and young adults with SCD living in Nigeria.
Description:
The study is a multi-center, prospective observational cohort study. Thus, it is designed to
be a longitudinal registry of strokes in children and young adults with SCA in Nigeria.
Participants will be recruited from multiple sites in Nigeria that agree to participate. This
study does not entail offering any intervention; all data collected will be based on standard
of care. As new information is obtained about the rate of stroke recurrence, risk factors for
strokes, and best treatment for strokes in children and young adults with SCA, the site
investigators will share this information with the participants in the registry and their
parents.
Children and young adults with SCA will be consented to participate in the Afolabi Stroke
Registry after a diagnosis of a stroke has been made within 3 months of the event. To enhance
retention, the Investigators developed strategies to reduce loss-to-follow-up, including
clear written participant instructions, reimbursing patient transportation costs for
follow-up visits outside standard care visits, and fortnightly study phone calls. Further,
the Investigators will request the names, addresses, and phone numbers of two family members
or friends who know how to reach the participant in the event of a missed appointment (this
information will be kept at each site and will not be entered into the central database). A
medical history and physical examination, magnetic resonance imaging/magnetic resonance
angiography (MRI/MRA), and neurological examination will be completed prior to enrollment of
participants to confirm their eligibility for the study. Data on patients' demographics,
stroke risk factors, and severity of strokes using the National Institute of Neurological
Disorders and Stroke (NINDS) Common Data Elements or modified Rankin scale at baseline and
annually. Children and young adults with SCA will be consented to participate in the Afolabi
Stroke Registry after a diagnosis of a stroke has been made within 3 months of the event. To
enhance retention, the Investigators developed strategies to reduce loss-to-follow-up,
including clear written participant instructions, reimbursing patient transportation costs
for follow-up visits outside standard care visits, and fortnightly study phone calls.
Further, the Investigators will request the names, addresses, and phone numbers of two family
members or friends who know how to reach the participant in the event of a missed appointment
(this information will be kept at each site and will not be entered into the central
database).A medical history and physical examination, MRI/MRA, and neurological examination
will be completed prior to enrollment of participants to confirm their eligibility for the
study. Data on patients' demographics, stroke risk factors, and severity of strokes using the
National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements or
modified Rankin scale at baseline and annually.
Each participant will be prospectively followed until at least 10 years. the Investigators
will collect and record all acute neurological events (overt stroke and TIA) requiring
hospitalization or emergency department visits during the study. Imaging and clinical data
collected as part of standard care will be used for secondary analysis. Research information,
including consent forms, questionnaires, and results of cognitive testing will be maintained
in a secure fashion in research charts in a locked file room or locked file cabinet, or in a
secure Research Electronic Data Capture (REDCap) database.
