Actively Recruiting
Stroke Prevention in Nigeria 2 Trial
Led by Vanderbilt University Medical Center · Updated on 2026-03-05
220
Participants Needed
2
Research Sites
307 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
A
Aminu Kano Teaching Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary goal of this study is to complete a multicenter single-arm, type I hybrid trial to assess the effectiveness of hydroxyurea therapy for primary stroke prevention in high-risk children with sickle cell anemia (SCA) living in Nigeria in routine care settings.
CONDITIONS
Official Title
Stroke Prevention in Nigeria 2 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of HbSS or HbSB0 confirmed by high-performance liquid chromatography (HPLC)
- Informed consent from parent/legal guardian and assent from patient if at least 7 years old
- Two Transcranial Doppler (TCD) velocity readings ≥180 cm/sec and <220 cm/sec or one reading ≥220 cm/sec
- Age between 5 and 12 years (assessment up to 13th birthday)
- Ability to swallow hydroxyurea capsules
You will not qualify if you...
- Prior stroke or transient ischemic attack (TIA) or moderate/severe neurological deficit
- Significant organ dysfunction or contraindication to hydroxyurea
- Already receiving blood transfusion or hydroxyurea therapy
- Significant cytopenias (ANC <1500, platelets <150,000/µl, reticulocytes <80,000/µl unless Hb >9 g/dl)
- Renal insufficiency (creatinine >0.8 mg/dl)
- History of seizures or epilepsy
- Presence of metal in body making MRI unsafe
- Children under 5 years old due to inability to swallow capsules
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Aminu Kano Teaching Hospital
Kano, Nigeria
Actively Recruiting
2
Murtala Muhammad Specialist Hospital
Kano, Nigeria
Actively Recruiting
Research Team
M
Michael R DeBaun, MD, MPH
CONTACT
L
Leshana Saint Jean, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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