drugset / Trial / NCT02675790
Moderate Dose Hydroxyurea for Secondary Stroke Prevention in Children With Sickle Cell Disease in Sub-Saharan Africa
Phase 3
Completed
120 enrolled
Vanderbilt University Medical Center
Aminu Kano Teaching Hospital · collabMurtala Muhammed Specialist Hospital · collab
RandomizedSingle-groupQuadruple-blindPrevention
Summary
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.
Timeline
- Start
- 2017-01
- Primary completion
- 2020-03-31
- Completion
- 2020-03-31
Publications
- Background 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.
- Background 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.
- Abdullahi SU, DeBaun MR, Jordan LC, Rodeghier M, Galadanci NA. Stroke Recurrence in Nigerian Children With Sickle Cell Disease: Evidence for a Secondary Stroke Prevention Trial. Pediatr Neurol. 2019 Jun;95:73-78. doi: 10.1016/j.pediatrneurol.2019.01.008. Epub 2019 Jan 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Hydroxyurea | Other / unclassified | 10 mg/kg | — |
| Comparator | Hydroxyurea | Other / unclassified | 20 mg/kg | — |