Stroke Prevention in Nigeria 2 Trial
SPRING-2
Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II: A Multicenter, Open-label, Single-arm Type I Hybrid Clinical Trial
2 other identifiers
interventional
220
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2024
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2024
CompletedFirst Posted
Study publicly available on registry
July 29, 2024
CompletedStudy Start
First participant enrolled
August 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2030
March 5, 2026
March 1, 2026
5.4 years
July 23, 2024
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence Rate of Clinical Stroke or TIA
The incidence rate of clinical stroke or TIA in participants treated with low- or moderate-dose hydroxyurea.
5 years
Secondary Outcomes (1)
Incidence of All-Cause Hospitalizations
5 years
Study Arms (1)
Low or Moderate Dose Hydroxyurea
EXPERIMENTALInitial treatment with Hydroxyurea at 10 mg/kg/day (range 7 to 15 mg/kg/day) for primary stroke prevention. Subsequent treatment with moderate-dose hydroxyurea (20 mg/kg/day (range 17.5 - 26 mg/kg/day)) based after at least two severe pain events requiring physician contact during the trial.
Interventions
The study intervention will include initial treatment with low-dose hydroxyurea therapy at 10 mg/kg/day (range 7 - 15 mg/kg/day), with subsequent increase to moderate dose hydroxyurea therapy at 20 mg/kg/day (range 17.5 - 26 mg/kg/day) after at least two severe events requiring physician contact.
Eligibility Criteria
You may qualify if:
- Diagnosis of HbSS or HbSB0 confirmed by high-performance liquid chromatography (HPLC);
- Informed consent from the parent/legal guardian and assent from the patient at least 7 years of age;
- Two TCD flow velocity readings of \>or equal to180 cm/sec and \< 220 cm/sec or one TCD velocity reading \> or equal to 220 cm/sec; typically the repeat TCD is performed on the same day so treatment can start immediately;
- Age between 5 and 12 years (assessment can take place up until the 13th birthday), which includes the peak age of onset of strokes in SCA, \~ 6 yo; and
- Ability to swallow the hydroxyurea capsule.
You may not qualify if:
- Prior stroke or TIA by history, or concern for moderate or severe neurological deficit based on a positive validated "10 questions" screening;
- Other significant organ system dysfunction or other contraindication to hydroxyurea;
- Children who are already on therapy with either blood transfusion or hydroxyurea therapy;
- Significant cytopenias (absolute neutrophil count (ANC) \<1500, platelets \<150,000/ul, reticulocytes \<80,000/ul, unless Hb is \> 9 g/dl\], renal insufficiency (creatinine \> 0.8 mg/dl); and
- History of seizures or diagnosis of epilepsy, and 6) metal in the body that would make MRI unsafe. The rationale for excluding children under 5 years old: Despite being a vulnerable age group for strokes, children younger than 5 years were excluded because a significant proportion of this population is unable to swallow a capsule, the only stable form of hydroxyurea available in Nigeria.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aminu Kano Teaching Hospital
Kano, Nigeria
Murtala Muhammad Specialist Hospital
Kano, Nigeria
Related Publications (2)
Adams RJ, McKie VC, Hsu L, Files B, Vichinsky E, Pegelow C, Abboud M, Gallagher D, Kutlar A, Nichols FT, Bonds DR, Brambilla D. Prevention of a first stroke by transfusions in children with sickle cell anemia and abnormal results on transcranial Doppler ultrasonography. N Engl J Med. 1998 Jul 2;339(1):5-11. doi: 10.1056/NEJM199807023390102.
PMID: 9647873BACKGROUNDAbdullahi SU, Jibir BW, Bello-Manga H, Gambo S, Inuwa H, Tijjani AG, Idris N, Galadanci A, Hikima MS, Galadanci N, Borodo A, Tabari AM, Haliru L, Suleiman A, Ibrahim J, Greene BC, Ghafuri DL, Rodeghier M, Slaughter JC, Kirkham FJ, Neville K, Kassim A, Trevathan E, Jordan LC, Aliyu MH, DeBaun MR. Hydroxyurea for primary stroke prevention in children with sickle cell anaemia in Nigeria (SPRING): a double-blind, multicentre, randomised, phase 3 trial. Lancet Haematol. 2022 Jan;9(1):e26-e37. doi: 10.1016/S2352-3026(21)00368-9.
PMID: 34971579BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael R DeBaun, MD, MPH
Vanderbilt University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Vice Chair, Chair, Clinical Research, Director, Vanderbilt/Meharry Center of SCD
Study Record Dates
First Submitted
July 23, 2024
First Posted
July 29, 2024
Study Start
August 5, 2024
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
June 30, 2030
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share