Epidemiology of Silent and Overt Strokes in Sickle Cell Disease (NCT03376893)
The Epidemiology of Silent and Overt Strokes in Adults With Sickle Cell Disease: a Prospective Cohort Study
๐ฉบ Plain-English Summary (8th-Grade Level)
Sickle Cell Disease (SCD) is a rare disease occurring in an estimated 100,000 individuals, often poor and underserved, in the US. Silent and overt strokes contribute significantly to morbidity in adults with SCD, resulting in functional impairment, challenges with school and job performance, and premature death. Five NIH-funded randomized controlled trials have identified therapies to prevent silent and overt strokes in children with SCD, including monthly blood transfusion therapy (for preventing initial and recurrent strokes) and hydroxyurea (for preventing initial strokes). Despite the observation that at least 99% of children with SCD in high-income countries reach adulthood, and approximately 60% of adults will experience one or more strokes (\~50% with silent strokes and \~10% with overt strokes), no stroke trials have established therapeutic approaches for adults with SCD. For adults with SCD, inadequate evidence-based guidelines exist for secondary stroke prevention strategies. Applying stroke prevention strategies in children may not be effective for stroke prevention in adults with SCD, particularly given the high rate of co-morbidities. Identifying subgroups of adults with SCD and higher incidence coupled with the contribution of established stroke risk factors in the general population (smoking, diabetes, obesity, renal disease) will provide the requisite data required for the first-ever phase III clinical trials focused on secondary stroke prevention in adults.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham โ Birmingham, Alabama
Age range: 18 Years
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (4 Sites)
- University of Alabama at Birmingham โ Birmingham, Alabama
- Washington University School of Medicine โ St Louis, Missouri
- Vanderbilt University Medical Center โ Nashville, Tennessee
- Vanderbilt University Medical Center โ Nashville, Tennessee
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Anemia, Sickle Cell
- Therapeutic Response Evaluation and Adherence Trial (TREAT) โ Cincinnati, Ohio
- A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease โ Birmingham, Alabama
- A Socio-ecological Approach for Improving Self-management in Adolescents With SCD โ Wilmington, Delaware
Explore by condition: All Anemia, Sickle Cell clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.