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Epidemiology of Silent and Overt Strokes in Sickle Cell Disease

NCT03376893 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2026-02-13

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER

  • University of Alabama at Birmingham

    collaborator OTHER

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Lori C. Jordan, PhD, MD · Vanderbilt University Medical Center

  • Michael R DeBaun, MD, MPH · Vanderbilt University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-02
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03376893 on ClinicalTrials.gov