Sickle Cell AnemiaSACREDNCT02769845

SACRED A Prospective Research Study to Reduce Stroke in Children With Sickle Cell Anemia

A study testing Hydroxyurea and TCD examination in people with Sickle Cell Anemia, run by Children's Hospital Medical Center, Cincinnati at 1 site in Dominican Republic.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Prospective screening and treatment study for children with Sickle Cell Anemia and increased stroke risk living in the Dominican Republic. Read more about this study

Who is it for?: Ages 3 to 15 years
Conditions the study is for: Sickle Cell Anemia
What is being tested?: Hydroxyurea and TCD examination
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 283 participants
Where: 1 siteDominican Republic
Study dates: 16 Mar 2016to 1 Oct 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

Pediatric participants with severe forms of sickle cell anemia (HbSS or HbSβ° thalassemia)
Age: between 3.0 and 15.0 years at the time of enrollment
Parent or guardian willing and able to provide informed consent
Ability to comply with study related treatments, evaluations, and follow-up
There are no exclusion criteria applicable to the TCD screening portion of SACRED.
For participants with conditional TCD velocities, the following criteria will disqualify them from the treatment phase of SACRED:

Who cannot join

Known medical condition making participation ill-advised (e.g., acute or chronic infectious disease including HIV, known allergy to hydroxyurea therapy, or malignancy)
Abnormal historical laboratory values (most recent pre-enrollment values):
Anemia: Hemoglobin concentration < 6.0 gm/dL
Reticulocytopenia: Absolute reticulocyte count < 100 x 10˄9/L with a hemoglobin concentration < 8.0 gm/dL
Neutropenia: Absolute neutrophil count (ANC) < 1.0 x 10˄9/L
Thrombocytopenia: Platelet count < 80 x10˄9 /L
Known abnormal renal function (serum creatinine >2X upper limit for age AND ≥ 1.0 mg/dL)
Pregnancy (for post-menarchal females only)

Trial locations and contacts

1 site in 1 country.

Dominican Republic1 site

Encargada del Servicio de Hematología-Oncología Hospital Infantil Dr. Robert Reid Cabral
Santo Domingo

Other trials in Dominican Republic

About this study

Official title: Stroke Avoidance for Children in REpublica Dominicana (SACRED): A Prospective Research Study to Reduce Stroke in Children With Sickle Cell Anemia

Prospective screening and treatment study for children with Sickle Cell Anemia and increased stroke risk living in the Dominican Republic.

Read the detailed description

SACRED involves a three-part study design, as outlined below, to include (1) initial TCD evaluation phase; (2) longitudinal TCD evaluation; and (3) treatment if warranted.

The initial evaluation portion of SACRED will involve obtaining TCD examinations on children with SCA between ages 3-15 years, who are followed at Hospital Infantil Robert Reid Cabral in Santo Domingo to evaluate their risk of stroke. Up to 500 patients will be enrolled. All patients, including those who are already on hydroxyurea and transfusion therapy (whether for stroke or other clinical indications), will be included to obtain a one-year cross-sectional description of TCD velocities in this patient population. Patients who are already on therapy and identified to have elevated TCD velocities will be eligible for the treatment portion of SACRED as a conditional or elevated velocity would suggest that their present therapy was not optimized.
In the longitudinal portion of SACRED, all enrolled children will undergo yearly TCD examination. The goal of serial examination is to help define the natural history of cerebrovascular disease, specifically to determine the incidence of new conditional or abnormal velocities. The goal is to obtain a total of 3 TCD examinations per enrolled patient, regardless of treatment status.
In the treatment phase of SACRED, those children with TCD velocities between 170-199 cm/sec will be eligible for protocol-directed hydroxyurea therapy. Most participants will initiate hydroxyurea treatment but those who are already on hydroxyurea and have conditional velocities will receive dose optimization. Participants will be followed until a common study termination date, defined as 3 years from the first treatment. Participants with abnormal TCD velocities ≥200 cm/sec will commence with transfusion therapy per current practice guidelines at the clinical site. Patients already on transfusion therapy identified to have conditional velocities will also be eligible for hydroxyurea and those with abnormal velocities may require re-calculation of transfusion dosing.

Conditions: Sickle Cell Anemia
Being tested: Hydroxyurea, TCD examination
Medical subject headings: Anemia, Sickle Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HydroxyureaDrug
drug to be administered
TCD examinationProcedure or surgery
TCD examinations on children with SCA between ages 3-15 years will be completed to evaluate their risk of stroke. All enrolled children will undergo yearly TCD examination. Participants with conditional TCD velocities on hydroxyurea therapy per study protocol will undergo TCD examinations every 6 months.

Study groups in NCT02769845
Study group	Role	What they receive
Longitudinal Portion	Experimental	All enrolled children will undergo yearly TCD examination. The goal of serial examination is to help define the natural history of cerebrovascular disease, specifically to determine the incidence of new conditional or abnormal velocities. The goal is to obtain a total of 3 TCD examinations per enrolled patient, regardless of treatment status. Receives: Procedure: TCD examination
Treatment Phase	Experimental	Those children with TCD velocities between 170-199 cm/sec will be eligible for protocol-directed hydroxyurea therapy. Most participants will initiate hydroxyurea treatment but those who are already on hydroxyurea and have conditional velocities will receive dose optimization. Participants will be followed until a common study termination date, defined as 3 years from the first treatment. Participants with abnormal TCD velocities ≥200 cm/sec will commence with transfusion therapy per current practice guidelines at the clinical site. Patients already on transfusion therapy identified to have conditional velocities will also be eligible for hydroxyurea and those with abnormal velocities may require re-calculation of transfusion dosing. Receives: Drug: Hydroxyurea; Procedure: TCD examination

What is being measured

The primary outcome is the main question the study is designed to answer.

Transcranial Doppler Ultrasound examinations
Serial TCD velocities will be measured yearly for participants not receiving hydroxyurea and every six months for participants receiving hydroxyurea during the trial. The outcome measure will be the highest TAMV obtained in the main intracranial arteries: middle cerebral artery (MCA), internal carotid artery (ICA), or internal carotid bifurcation (BIF). Subsequent TCD velocities will be compared to the baseline TCD values to describe the potential efficacy of hydroxyurea to reduce elevated TCD velocities.
Measured: 0-24 months

Secondary outcomes (1)

Hydroxyurea toxicities
This measure will be performed at least quarterly throughout the trial, and monthly during dose escalation by recording the CBC and Retic count.
Measured: 0-30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 20161 Oct 2022

First posted12 May 2016 (estimated)
Study start16 Mar 2016
Primary completion1 Jul 2019
Study completion1 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 283 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02769845
Sponsor's protocol ID: 2015-8767 SACRED
Acronym: SACRED
Status last verified: Jul 2025
First submitted: 10 May 2016
Last updated: 22 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Nieves RM, Latham T, Marte N, Berges M, Sanchez LM, Urcuyo G, Florencio C, Gonzalez C, Del Villar P, Chen S, Ramirez D, Reyes P, Marinez M, Matos E, Jeste ND, Stuber SE, Schultz WH, Lane AC, Mena R, Ware RE. Stroke prevention in Hispanic children with sickle cell anemia: the SACRED trial. Blood Adv. 2025 Apr 22;9(8):1791-1800. doi: 10.1182/bloodadvances.2024014327.
PubMed 39820633
Jeste ND, Sanchez LM, Urcuyo GS, Berges ME, Luden JP, Stuber SE, Latham TS, Mena R, Nieves RM, Ware RE. Stroke Avoidance for Children in REpublica Dominicana (SACRED): Protocol for a Prospective Study of Stroke Risk and Hydroxyurea Treatment in Sickle Cell Anemia. JMIR Res Protoc. 2017 Jun 2;6(6):e107. doi: 10.2196/resprot.7491.
PubMed 28576754

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sickle Cell Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stroke Avoidance for Children in REpublica Dominicana (SACRED): A Prospective Research Study to Reduce Stroke in Children With Sickle Cell Anemia
ClinicalTrials.gov ID: NCT02769845
Acronym / sponsor ID: SACRED / 2015-8767 SACRED
Conditions: Sickle Cell Anemia
Study type: Interventional
Recruitment status: Completed
Enrolment: 283 participants (actual)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Collaborators: Hospital Infantil Dr. Robert Reid Cabral
Study start: 16 Mar 2016 (actual)
Primary completion: 1 Jul 2019 (actual)
Study completion: 1 Oct 2022 (actual)
First posted: 12 May 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prospective screening and treatment study for children with Sickle Cell Anemia and increased stroke risk living in the Dominican Republic.

Detailed description

SACRED involves a three-part study design, as outlined below, to include (1) initial TCD evaluation phase; (2) longitudinal TCD evaluation; and (3) treatment if warranted.

The initial evaluation portion of SACRED will involve obtaining TCD examinations on children with SCA between ages 3-15 years, who are followed at Hospital Infantil Robert Reid Cabral in Santo Domingo to evaluate their risk of stroke. Up to 500 patients will be enrolled. All patients, including those who are already on hydroxyurea and transfusion therapy (whether for stroke or other clinical indications), will be included to obtain a one-year cross-sectional description of TCD velocities in this patient population. Patients who are already on therapy and identified to have elevated TCD velocities will be eligible for the treatment portion of SACRED as a conditional or elevated velocity would suggest that their present therapy was not optimized.
In the longitudinal portion of SACRED, all enrolled children will undergo yearly TCD examination. The goal of serial examination is to help define the natural history of cerebrovascular disease, specifically to determine the incidence of new conditional or abnormal velocities. The goal is to obtain a total of 3 TCD examinations per enrolled patient, regardless of treatment status.
In the treatment phase of SACRED, those children with TCD velocities between 170-199 cm/sec will be eligible for protocol-directed hydroxyurea therapy. Most participants will initiate hydroxyurea treatment but those who are already on hydroxyurea and have conditional velocities will receive dose optimization. Participants will be followed until a common study termination date, defined as 3 years from the first treatment. Participants with abnormal TCD velocities ≥200 cm/sec will commence with transfusion therapy per current practice guidelines at the clinical site. Patients already on transfusion therapy identified to have conditional velocities will also be eligible for hydroxyurea and those with abnormal velocities may require re-calculation of transfusion dosing.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Longitudinal Portion	Experimental	Procedure: TCD examinationAll enrolled children will undergo yearly TCD examination. The goal of serial examination is to help define the natural history of cerebrovascular disease, specifically to determine the incidence of new conditional or abnormal velocities. The goal is to obtain a total of 3 TCD examinations per enrolled patient, regardless of treatment status.
Treatment Phase	Experimental	Drug: Hydroxyurea, Procedure: TCD examinationThose children with TCD velocities between 170-199 cm/sec will be eligible for protocol-directed hydroxyurea therapy. Most participants will initiate hydroxyurea treatment but those who are already on hydroxyurea and have conditional velocities will receive dose optimization. Participants will be followed until a common study termination date, defined as 3 years from the first treatment. Participants with abnormal TCD velocities ≥200 cm/sec will commence with transfusion therapy per current practice guidelines at the clinical site. Patients already on transfusion therapy identified to have conditional velocities will also be eligible for hydroxyurea and those with abnormal velocities may require re-calculation of transfusion dosing.

Who may qualify

Ages: 3 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Pediatric participants with severe forms of sickle cell anemia (HbSS or HbSβ° thalassemia)
Age: between 3.0 and 15.0 years at the time of enrollment
Parent or guardian willing and able to provide informed consent
Ability to comply with study related treatments, evaluations, and follow-up
There are no exclusion criteria applicable to the TCD screening portion of SACRED.

Key exclusion criteria (8 listed)

Known medical condition making participation ill-advised (e.g., acute or chronic infectious disease including HIV, known allergy to hydroxyurea therapy, or malignancy)
Abnormal historical laboratory values (most recent pre-enrollment values):
Pregnancy (for post-menarchal females only)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hydroxyureadrug to be administered	Drug	Treatment Phase
TCD examinationTCD examinations on children with SCA between ages 3-15 years will be completed to evaluate their risk of stroke. All enrolled children will undergo yearly TCD examination. Participants with conditional TCD velocities on hydroxyurea therapy per study protocol will undergo TCD examinations every 6 months.	Procedure or surgery	Longitudinal Portion, Treatment Phase

Primary outcome

Transcranial Doppler Ultrasound examinations
Time frame: 0-24 months
Serial TCD velocities will be measured yearly for participants not receiving hydroxyurea and every six months for participants receiving hydroxyurea during the trial. The outcome measure will be the highest TAMV obtained in the main intracranial arteries: middle cerebral artery (MCA), internal carotid artery (ICA), or internal carotid bifurcation (BIF). Subsequent TCD velocities will be compared to the baseline TCD values to describe the potential efficacy of hydroxyurea to reduce elevated TCD velocities.

1 secondary outcome

Hydroxyurea toxicities
Time frame: 0-30 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Derived from this study: PubMed 39820633Nieves RM, Latham T, Marte N, Berges M, Sanchez LM, Urcuyo G, Florencio C, Gonzalez C, Del Villar P, Chen S, Ramirez D, Reyes P, Marinez M, Matos E, Jeste ND, Stuber SE, Schultz WH, Lane AC, Mena R, Ware RE. Stroke prevention in Hispanic children with sickle cell anemia: the SACRED trial. Blood Adv. 2025 Apr 22;9(8):1791-1800. doi: 10.1182/bloodadvances.2024014327.
Derived from this study: PubMed 28576754Jeste ND, Sanchez LM, Urcuyo GS, Berges ME, Luden JP, Stuber SE, Latham TS, Mena R, Nieves RM, Ware RE. Stroke Avoidance for Children in REpublica Dominicana (SACRED): Protocol for a Prospective Study of Stroke Risk and Hydroxyurea Treatment in Sickle Cell Anemia. JMIR Res Protoc. 2017 Jun 2;6(6):e107. doi: 10.2196/resprot.7491.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Russell Ware, MD, PhD principal investigator

Children's Hospital Medical Center, Cincinnati

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hydroxyurea and TCD examination in people with Sickle Cell Anemia, run by Children's Hospital Medical Center, Cincinnati at 1 site in Dominican Republic.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transcranial Doppler Ultrasound examinations (time frame: 0-24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02769845, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.