Sickle Cell DiseaseNCT04800809
The Afolabi Stroke Registry for Children and Young Adults With SCD in Northern Nigeria
An observational study of Sickle Cell Disease and Stroke, run by Vanderbilt University Medical Center at 3 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 5 to 26 years
- Conditions the study is for
- Sickle Cell Disease, Stroke, Neurologic Manifestations
- How many people
- 350 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Apr 2020to 31 Dec 2023
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and young adults (5-26 years of age) with a confirmed diagnosis of sickle cell anemia living in northern Nigeria. Children and young adults with sickle cell anemia 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.
Who may be able to join
- Participants with sickle cell disease confirmed with hemoglobin electrophoresis or HPLC
- Age 5 to 26 years old
- Present within three months of stroke event that is diagnosed as a stroke by the local health care provider
- Medical records are available for review for the stroke event that occurred within 3 months
- Prior treatment in the SPIN, SPRING and SPRINT trials for primary or secondary stroke prevention
Who cannot join
- Participants judged to be non-compliant by the hematologist based on previous experience in terms of clinic appointments and following advice
- Participants with contraindications to MRI, including individuals with MRI- incompatible foreign metal objects
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Nigeria2 sites
Jamil Galadanci
Kano, PMB 3452
Aminu Kano Teaching Hospital
Kano
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-9000
About this study
Official title: Stroke Registry for Children and Young Adults With Sickle Cell Disease in Nigeria - The Afolabi Stroke Registry
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.
Read the detailed 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.
- Conditions
- Sickle Cell Disease, Stroke, Neurologic Manifestations, Neurological Morbidity, Sickle Cell Anemia in Children, Sickle Cell Anemia
- Being tested
- This study does not entail offering any intervention; all data collected will be based on standard of care.
- Keywords
- sickle cell anemia, northern Nigeria, low-resource setting, stroke registry, children
- Medical subject headings
- Anemia, Sickle Cell, Stroke, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study does not entail offering any intervention; all data collected will be based on standard of care.Other
This study does not entail offering any intervention; all data collected will be based on standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Children and young adults with SCD and stroke | * Participants with SCD confirmed with hemoglobin electrophoresis or high pressure liquid chromatography (HPLC)
* Age 5 to 26 years old
* Present within three months of stroke event that is diagnosed as a stroke by the local health care provider
* Medical records are available for review for the stroke event that occurred within 3 months Receives: Other: This study does not entail offering any intervention; all data collected will be based on standard of care. | |
| The participants in SPIN and SPRING and SPRINT Trials | The participants enrolled in our previous primary and secondary stroke prevention trials in northern Nigeria; SPIN and SPRING (children with SCD with normal and abnormal TCD measurements; NCT02560935 and NCT01801423), SPRINT (children with SCD and strokes; NCT02675790) Trials for ascertainment of incidences rates of strokes in children and young adults receiving standard care after completion of primary stroke prevention trials. For this purpose, we will enroll these participants to follow their progress after completion of the trials. No intervention is planned, only to follow the participants with and without abnormal TCD measurements and with and without strokes. Receives: Other: This study does not entail offering any intervention; all data collected will be based on standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of stroke recurrence rates in children and young adults with SCD living in Nigeria.
To determine the incidence of stroke recurrence rates in children and young adults with SCD living in Nigeria. For this purpose, an electronic online registry will be created. All children and young adults ages between 5 to 26 years old with SCD who are being followed at the participating sites in Nigeria will be consented to enroll to the Afolabi SCD Stroke Registry in Nigeria. The Investigators will collect and document all acute neurological events (stroke and transient ischemic attacks (TIA) requiring hospitalization or ED visits during the study. Imaging and clinical data collected as part of standard care will be used for secondary analysis.
Measured: 10 years
Secondary outcomes (3)
Non-SCD and SCD risk factors for stroke in children and young adults with SCD.
To assess non-SCD risk factors in combination with SCD risk factors for stroke in children and young adults (16-25 years of age) with SCD. For this purpose, all participants will also be screened as per standard care for conventional risk factors of stroke (hypertension, smoking, diabetes, obesity, renal disease, cardiomyopathy, and atrial fibrillation).
Measured: 10 years
The incidence of neurological morbidity and mortality in children and young adults with SCD.
To determine the one year and two to five-year incidence of neurological morbidity and mortality in children and young adults with SCD. Data gathered from this registry will advance the care of children and young adults with SCD not only in Africa but will fill an information gap to improve the neurological outcomes in other low-resource settings.
Measured: 10 years
Long-term follow-up of the participants in the SPIN, SPRING, and SPRINT Trials
To follow the participants in SPIN and SPRING (those with normal and abnormal TCD measurements; NCT02560935 and NCT01801423) and SPRINT (children with strokes; NCT02675790) long-term for ascertainment of incidences rates of strokes in children and young adults receiving standard care after completion of primary stroke prevention trials. For this purpose, the Investigators will enroll participants in the primary and secondary stroke trials to follow their progress after completion of the trial. No intervention is planned, only to follow the participants with and without abnormal transcranial Doppler measurements and with and without strokes.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Apr 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 Vanderbilt University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Aminu Kano Teaching Hospital, Murtala Muhammed Specialist Hospital, Bayero University Kano, Nigeria
- Responsible party
- Principal investigator, Michael DeBaun, Vanderbilt University Medical Center
- Investigators
- Michael R DeBaun, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800809
- Sponsor's protocol ID
- 191560
- Status last verified
- Apr 2024
- First submitted
- 15 Mar 2021
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Registry for Children and Young Adults With Sickle Cell Disease in Nigeria - The Afolabi Stroke Registry
- ClinicalTrials.gov ID
- NCT04800809
- Acronym / sponsor ID
- 191560
- Conditions
- Sickle Cell Disease, Stroke, Neurologic Manifestations, Neurological Morbidity, Sickle Cell Anemia in Children, Sickle Cell Anemia
- Keywords
- sickle cell anemia, northern Nigeria, low-resource setting, stroke registry, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Aminu Kano Teaching Hospital, Murtala Muhammed Specialist Hospital, Bayero University Kano, Nigeria
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 Mar 2021 (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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children and young adults with SCD and stroke | – | Other: This study does not entail offering any intervention; all data collected will be based on standard of care.* Participants with SCD confirmed with hemoglobin electrophoresis or high pressure liquid chromatography (HPLC) * Age 5 to 26 years old * Present within three months of stroke event that is diagnosed as a stroke by the local health care provider * Medical records are available for review for the stroke event that occurred within 3 months |
| The participants in SPIN and SPRING and SPRINT Trials | – | Other: This study does not entail offering any intervention; all data collected will be based on standard of care.The participants enrolled in our previous primary and secondary stroke prevention trials in northern Nigeria; SPIN and SPRING (children with SCD with normal and abnormal TCD measurements; NCT02560935 and NCT01801423), SPRINT (children with SCD and strokes; NCT02675790) Trials for ascertainment of incidences rates of strokes in children and young adults receiving standard care after completion of primary stroke prevention trials. For this purpose, we will enroll these participants to follow their progress after completion of the trials. No intervention is planned, only to follow the participants with and without abnormal TCD measurements and with and without strokes. |
Who may qualify
- Ages
- 5 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and young adults (5-26 years of age) with a confirmed diagnosis of sickle cell anemia living in northern Nigeria. Children and young adults with sickle cell anemia 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.
Key inclusion criteria (5 listed)
- Participants with sickle cell disease confirmed with hemoglobin electrophoresis or HPLC
- Age 5 to 26 years old
- Present within three months of stroke event that is diagnosed as a stroke by the local health care provider
- Medical records are available for review for the stroke event that occurred within 3 months
- Prior treatment in the SPIN, SPRING and SPRINT trials for primary or secondary stroke prevention
Key exclusion criteria (2 listed)
- Participants judged to be non-compliant by the hematologist based on previous experience in terms of clinic appointments and following advice
- Participants with contraindications to MRI, including individuals with MRI- incompatible foreign metal objects
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 |
|---|---|---|
| This study does not entail offering any intervention; all data collected will be based on standard of care.This study does not entail offering any intervention; all data collected will be based on standard of care. | Other | Children and young adults with SCD and stroke, The participants in SPIN and SPRING and SPRINT Trials |
Primary outcome
The incidence of stroke recurrence rates in children and young adults with SCD living in Nigeria.
Time frame: 10 years
To determine the incidence of stroke recurrence rates in children and young adults with SCD living in Nigeria. For this purpose, an electronic online registry will be created. All children and young adults ages between 5 to 26 years old with SCD who are being followed at the participating sites in Nigeria will be consented to enroll to the Afolabi SCD Stroke Registry in Nigeria. The Investigators will collect and document all acute neurological events (stroke and transient ischemic attacks (TIA) requiring hospitalization or ED visits during the study. Imaging and clinical data collected as part of standard care will be used for secondary analysis.
3 secondary outcomes
Non-SCD and SCD risk factors for stroke in children and young adults with SCD.
Time frame: 10 years
The incidence of neurological morbidity and mortality in children and young adults with SCD.
Time frame: 10 years
Long-term follow-up of the participants in the SPIN, SPRING, and SPRINT Trials
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michael R DeBaun, MD, MPH principal investigator
Vanderbilt University Medical Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and Stroke, run by Vanderbilt University Medical Center at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Nigeria, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of stroke recurrence rates in children and young adults with SCD living in Nigeria. (time frame: 10 years). 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 23 Apr 2024.