Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II (SPRING)
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|ClinicalTrials.gov Identifier: NCT02560935|
Recruitment Status : Active, not recruiting
First Posted : September 25, 2015
Last Update Posted : May 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Stroke||Drug: Hydroxyurea (Moderate Dose) Drug: Hydroxyurea (Low Dose)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||440 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Primary Prevention of Stroke in Children With Sickle Cell Disease in Sub-Saharan Africa II|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Moderate Dose Hydroxyurea
Hydroxyurea at 20 mg/kg/day (range 17.5 to 26 mg/kg/day) for primary stroke prevention.
Drug: Hydroxyurea (Moderate Dose)
The study intervention will include moderate dose hydroxyurea therapy at 20 mg/kg/day (range 17.5 - 26 mg/kg/day) for 36 months.
Other Name: Hydrea
Active Comparator: Low Dose Hydroxyurea
Hydroxyurea at 10 mg/kg/day (range 7 to 15 mg/kg/day) for primary stroke prevention.
Drug: Hydroxyurea (Low Dose)
The study intervention will include random allocation to low dose hydroxyurea therapy at 10 mg/kg/day (range 7 - 15 mg/kg/day) for 36 months.
Other Name: Hydrea
- Incidence rate of clinical stroke or TIA [ Time Frame: 3 Years ]To determine the efficacy of moderate vs. low dose hydroxyurea therapy for primary stroke prevention. Among over 10,000 children actively followed with SCA, ages 5 to 12 years. There will be a total of 110 participants in each treatment group followed for 3 years. We will have at least 90% power to detect a 66% relative risk reduction (based on our feasibility trial demonstrating that after 3 months, 2/3rds of participants had normal TCD measurements), with an alpha level of 0.05 and a dropout rate of 10%.
- Incidence of all cause hospitalizations [ Time Frame: 3 years ]To determine the efficacy of moderate dose hydroxyurea therapy for decreasing the incidence of all cause-hospitalization for any cause (pain, acute chest syndrome, infection, or other) when compared to low dose hydroxyurea therapy.
- Long-term safety of hydroxyurea therapy - Completed [ Time Frame: 3 Years ]To assess the long-term safety of hydroxyurea therapy (6.5 years) in participants from the feasibility trial with an elevated TCD measurement (n=25) when compared to children with an initial normal TCD (n= 210 followed for at least 3 years).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02560935
|Barau Dikko Teaching Hospital/Kaduna State University|
|Aminu Kano Teaching Hospital|
|Murtala Muhammad Specialist Hospital|
|Principal Investigator:||Michael R. DeBaun, MD, MPH||Vanderbilt University Medical Center|