Stroke Clinical Trial
— SPRINTOfficial title:
Hydroxyurea for Stroke Prevention in Children With Sickle Cell Disease in Sub-Saharan Africa
NCT number | NCT02675790 |
Other study ID # | 141077 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | March 31, 2020 |
Verified date | January 2022 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall goal of the proposed study is to determine the effectiveness of hydroxyurea therapy for secondary stroke prevention and prevention of other neurological events in children with SCA with an acute overt stroke.
Status | Completed |
Enrollment | 120 |
Est. completion date | March 31, 2020 |
Est. primary completion date | March 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 16 Years |
Eligibility | Inclusion Criteria: - Children ages 1 to 16 years of age with sickle cell anemia confirmed by hemoglobin electrophoresis evaluation or high performance liquid chromatography (HPLC); - Informed consent from a parent or legal guardian and assent of participants; - Children with presence of new stroke up to and including 30 days prior to signing the informed consent; - Acceptance of HU therapy for at least three years. Exclusion Criteria: - Children with history of stroke with event occurring more than 30 days prior to signing the informed consent; - Confirmed pregnancy or considering family planning - due to possible hydroxyurea-induced congenital anomalies or abnormal fetal growth. Adolescents who have started their menses must have a pregnancy test done every month prior to getting a prescription for HU; - Children who are already on blood transfusion or HU therapy; - Other exclusions: significant cytopenias [absolute neutrophil count (ANC) <1500/ul, platelets <150,000/ul, reticulocytes <80,000/ul, unless Hb is > 9 g/dl], renal insufficiency (creatinine > 0.8 mg/dl); other significant organ system dysfunction, or other contraindication to HU therapy; and history of seizures or diagnosis of epilepsy; - Other significant organ system dysfunction based on the site investigators discretion; - Any other condition, such as malnutrition, or chronic illness, which in the opinion of the site's Principal Investigator makes study therapy not advisable or unsafe; - Active infections: bacterial, viral or fungal (tuberculosis, malaria, active hepatitis, osteomyelitis); - Active chronic leg ulcers. |
Country | Name | City | State |
---|---|---|---|
Nigeria | Aminu Kano Teaching Hospital | Kano | |
Nigeria | Murtala Muhammad Specialist Hospital | Kano |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | Aminu Kano Teaching Hospital, Murtala Muhammed Specialist Hospital |
Nigeria,
Kassim AA, Galadanci NA, Pruthi S, DeBaun MR. How I treat and manage strokes in sickle cell disease. Blood. 2015 May 28;125(22):3401-10. doi: 10.1182/blood-2014-09-551564. Epub 2015 Mar 30. — View Citation
Ohene-Frempong K, Weiner SJ, Sleeper LA, Miller ST, Embury S, Moohr JW, Wethers DL, Pegelow CH, Gill FM. Cerebrovascular accidents in sickle cell disease: rates and risk factors. Blood. 1998 Jan 1;91(1):288-94. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Prevalence of stroke and incidence of recurrent strokes | To assess prevalence of strokes and incidence of recurrent strokes among individuals with SCD ages 1 - 16 at active study site from January 1, 2014 to June 30, 2017. | 42 months | |
Primary | Recurrence of clinically overt stroke, transient ischemic attack or death | To assess the effectiveness of moderate dose HU therapy at 20 mg/kg/day for secondary stroke prevention when compared to low dose HU therapy at 10 mg/kg/day in children with SCA. Within 30 days after the onset of a first stroke, children 1 to 16 years of age with SCA will be randomized to receive moderate dose HU therapy at 20 mg/kg/day (study group) or low dose HU therapy at 10 mg/kg/day (control group) with monthly follow-up for at least 36 months per participant. Parents will be educated on how to recognize signs and symptoms of a stroke. The rate of stroke recurrence will be measured using standardized neurological examinations (Pediatric NIH Stroke Scale). | 36 months | |
Secondary | Incidence of all cause hospitalizations | To determine whether moderate HU therapy at 20 mg/kg/day decreases the rate of all-cause hospitalizations when compared to low dose HU therapy at 10 mg/kg/day with monthly follow-up for at least 36 months per participant. | 36 months |
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