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Can a common drug shield children with sickle cell from stroke?

NCT ID NCT03948867

Prevention Sponsor: Children's Hospital Medical Center, Cincinnati 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This trial asks whether hydroxyurea, a daily oral medication, can reduce the risk of a first stroke in children with sickle cell anemia. Researchers will use transcranial Doppler (TCD) ultrasound to measure blood flow in the brain, a key indicator of stroke risk, in children aged 2 to 16 in Tanzania. Participants with elevated risk will receive hydroxyurea, and the study will track changes in TCD velocities over a year to see if the drug helps lower their stroke risk.

What this could mean

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

Active substance
Hydroxyurea, a daily oral medication, plus transcranial Doppler (TCD) ultrasound screening to assess stroke risk.
What this could lead to
If effective, this could establish a practical strategy to prevent first strokes in children with sickle cell anemia in low-resource settings.
What could go wrong
The trial is early (Phase 2) and focuses on a biomarker (TCD velocity) rather than actual stroke events, so benefits may not translate directly. Hydroxyurea can cause side effects like bone marrow suppression.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

202 people

The number who actually took part.

Started

Apr 2019

Expected to finish

Dec 2026

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.

Ages

2 to 16 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: * Willingness to sign informed consent * Willingness to follow all study procedures * Available for study visits for the duration of the study and no plans to move away from study center. * Confirmed diagnosis of Sickle Cell Anemia (SCA) by haemoglobin electrophoresis. * Able to take oral medication and follow hydroxyurea treatment schedule. Exclusion Criteria: There are no permanent exclusion criteria for participants to enroll in the screening TCD portion of SPHERE. Temporary, time-limited exclusion criteria for the screening TCD portion include the following: * Febrile illness within the past two weeks. (Temporary Exclusion) * Hospitalized within the past two weeks. (Temporary Exclusion) * Transfusion within the past two weeks. (Temporary Exclusion) Patients who enroll in the screening portion, have a conditional or abnormal TCD, and are eligible to start hydroxyurea will be excluded from receiving study treatment if they meet any of the following criteria: * Abnormal pre-enrolment laboratory values (Temporary Exclusion) * Known medical condition making participation ill-advised. * Known allergic reactions to components of hydroxyurea. * Previous history of stroke. * Currently pregnant or lactating.

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Conditions

The condition(s) this trial relates to.

sickle cell disease stroke disorder prevention target

As listed by the trial registrant

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

Sickle cell anemia in children

Contacts and locations

Locations

  • Bugando Medical Centre

    Mwanza, Tanzania

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

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