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Hidden brain damage in young sickle cell patients: new study aims to find answers

NCT ID NCT04808778

Knowledge-focused Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study looks at how common strokes and silent brain injuries are in young adults (ages 16-25) with sickle cell anemia, especially in Nigeria where the disease is widespread. Researchers will use brain scans and blood tests to check for damage and identify risk factors like high blood pressure or diabetes. The goal is to find better ways to prevent strokes in this high-risk group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hydroxyurea therapy (moderate dose of 20 mg/kg/day)
What this could lead to
If successful, this could identify key risk factors for stroke in young adults with sickle cell anemia, paving the way for targeted prevention strategies in low-resource settings.
What could go wrong
This is an observational study with a small sample size (250 participants) in one region of Nigeria, so results may not apply broadly. The study does not test a new treatment, so direct patient benefits are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

250 people

The number who actually took part.

Started

May 2021

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

A total of 250 participants with sickle cell anemia between 16 through 25 years of age living in northern Nigeria receiving care at the Aminu Kano Teaching Hospital in Kano Nigeria.

Ages

16 to 26 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with hemoglobin S-S or Sβ0 thalassemia confirmed by hemoglobin electrophoresis or High-Performance Liquid Chromatography (HPLC); 2. Participant is 16 through 25 years of age; 3. 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); 4. Participant resides within an hour driving distance from the medical center to facilitate weekly phone calls between the scheduled monthly clinic visits; 5. Participant is willing to be enrolled and followed for the duration of the study. Exclusion Criteria: 1. Young adults with co-morbidities that may have an impact on neurological status, such as epilepsy; 2. Young adults enrolled in clinical trials upon entry; 3. Participants with an implanted defibrillator or certain other implanted electronic or metallic devices contraindicated for MRI; 4. Young adults with known HIV diagnosis; 5. Any other condition or chronic illness, which in the opinion of the site's Principal Investigator (PI) makes participation ill-advised or unsafe.

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Conditions

The condition(s) this trial relates to.

ischemic stroke sickle cell disease cerebral infarction prevention target MRI defined brain infarct prevention target stroke disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sickle cell anemia Sickle cell disease Silent cerebral infarct Silent stroke Stroke Stroke, ischemic

Contacts and locations

Locations

  • Aminu Kano Teaching Hospital

    Kano, Nigeria

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-9000, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.