Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II (SPRING)
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|ClinicalTrials.gov Identifier: NCT02560935|
Recruitment Status : Recruiting
First Posted : September 25, 2015
Last Update Posted : March 22, 2017
|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 therapy at 20 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 therapy 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 [ 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02560935
|Contact: Michael R. DeBaun, MD, MPH||615-875-3040 ext email@example.com|
|Contact: Muktar Aliyu, MBBS, MPH, DrPH||615-343-4174/615-3434-0626||muktar.aliyu@Vanderbilt.Edu|
|Barau Dikko Teaching Hospital/Kaduna State University||Not yet recruiting|
|Contact: Halima Bello-Manga, MBBS, MPH, FMCPath +2348033470592 firstname.lastname@example.org|
|Contact: Lawal Haliru, MBBS, FWACP, PGDPA +234 8036896210 email@example.com|
|Aminu Kano Teaching Hospital||Recruiting|
|Contact: Shehu U. Abdullahi, MD, FWACPaed 234-802-850-3832 firstname.lastname@example.org|
|Contact: Najibah Galadanci, MBBS, MPH 234-803-700-5452 email@example.com|
|Principal Investigator: Najibah Galadanci, MBBS,FMCPath,MPH|
|Murtala Muhammad Specialist Hospital||Recruiting|
|Contact: Binta W. Jibir, MBBS, MTroped, FWACP 234-803-700-2249 firstname.lastname@example.org|
|Contact: Awwal I Gambo 234-8052886441 email@example.com|
|Principal Investigator:||Michael R. DeBaun, MD, MPH||Vanderbilt University Medical Center|