Status:
ACTIVE_NOT_RECRUITING
Stroke Prevention in Young Adults With Sickle Cell Anemia
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Aminu Kano Teaching Hospital
Conditions:
Sickle Cell Disease
Sickle Cell Anemia
Eligibility:
All Genders
16-26 years
Brief Summary
Sickle cell disease (SCD) is the most common genetic disease, affecting about 25 million people worldwide. Approximately 150,000 Nigerian children are born each year with sickle cell disease (SCD), ma...
Detailed Description
The Investigator's global hypothesis, to be tested eventually in an NIH-funded phase III controlled trial, is that hydroxyurea at a fixed moderate dose of 20 mg/kg is safe and effective for primary an...
Eligibility Criteria
Inclusion
- Patients with hemoglobin S-S or Sβ0 thalassemia confirmed by hemoglobin electrophoresis or High-Performance Liquid Chromatography (HPLC);
- Participant is 16 through 25 years of age;
- Informed consent from participants above 18 years, and informed consent from a parent or legal guardian and assent of participants aged \< 18 years (assessment can take place up until the 26th birthday);
- Participant resides within an hour driving distance from the medical center to facilitate weekly phone calls between the scheduled monthly clinic visits;
- Participant is willing to be enrolled and followed for the duration of the study.
Exclusion
- Young adults with co-morbidities that may have an impact on neurological status, such as epilepsy;
- Young adults enrolled in clinical trials upon entry;
- Participants with an implanted defibrillator or certain other implanted electronic or metallic devices contraindicated for MRI;
- Young adults with known HIV diagnosis;
- Any other condition or chronic illness, which in the opinion of the site's Principal Investigator (PI) makes participation ill-advised or unsafe.
Key Trial Info
Start Date :
May 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2029
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04808778
Start Date
May 17 2021
End Date
June 1 2029
Last Update
September 5 2025
Active Locations (2)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-9000
2
Aminu Kano Teaching Hospital
Kano, Nigeria