Clinical Trial: Hydroxyurea in Young Children With Sickle Cell Anemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effects of Hydroxyurea on the Prevention of Chronic Organ Damage in Young Children With Sickle Cell Anemia
Brief Summary: The purpose of this study is to asses prospectively the safety and efficacy of hydroxyurea therapy in children with Sickle cell Anemia between ages 18 months and 5 years, with special emphasis on the ability of hydroxyurea to prevent or reverse chronic organ damage.
Detailed Summary: Previous studies have shown that hydroxyurea therapy in adults and older children with SCA improves laboratory parameters and ameliorates the clinical severity of disease. Little is known, however, about the effects of hydroxyurea on the chronic organ damage that occurs in patients with SCA and leads to significant morbidity and mortality in young adults. The objectives of this study are to assess the safety and efficacy of HU in young children with SCA and to determine whether HU preserves renal function, reduces transcranial doppler ultrasound (TCD) values, and prevents development of brain ischemia as evidenced by MRI/MRA imaging. In addition, we will evaluate the effects of hydroxyurea on quality of life
Sponsor: Duke University
Current Primary Outcome:
- Transcranial doppler ultrasound velocity [ Time Frame: 2 years ]
- Magnetic resonance imaging/angiography [ Time Frame: 2 years ]
- Glomerular Filtration Rate [ Time Frame: 2 years ]
- Quality of Life [ Time Frame: 2 years ]
- Neurocognitive outcomes [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Growth parameters [ Time Frame: 2 years ]
- Hematological parameters [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Duke University
Dates:
Date Received: August 21, 2007
Date Started: April 2002
Date Completion:
Last Updated: August 22, 2007
Last Verified: August 2007
