The Afolabi Stroke Registry for Children and Young Adults With SCD in Northern Nigeria

NCT04800809 | Completed DMC

• 1 other identifier: 191560
• Study Type: observational
• Target: 350
• Locations: 2 countries
• Sites: 3

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  10 years

Secondary Outcomes (3)

• Non-SCD and SCD risk factors for stroke in children and young adults with SCD.

  10 years

• The incidence of neurological morbidity and mortality in children and young adults with SCD.

  10 years

• Long-term follow-up of the participants in the SPIN, SPRING, and SPRINT Trials

  10 years

Study Arms (2)

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

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.

Other: This study does not entail offering any intervention; all data collected will be based on standard of care.

Interventions

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.

Children and young adults with SCD and stroke; The participants in SPIN and SPRING and SPRINT Trials

Eligibility Criteria

• Age: 5 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Aminu Kano Teaching Hospital: collaborator
• Murtala Muhammed Specialist Hospital: collaborator
• Bayero University Kano, Nigeria: collaborator

Study Sites (3)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-9000, United States

Location

Jamil Galadanci

Kano, PMB 3452, Nigeria

Location

Aminu Kano Teaching Hospital

Kano, Nigeria

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Stroke; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael R DeBaun, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice Chair, Clinical and Translational Research

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 16, 2021
• Study Start: April 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NG (2); US (1)