Sickle Cell Disease and CardiovAscular Risk - Red Cell Exchange Trial (SCD-CARRE) (NCT04084080)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Age 18 years or older
2. Diagnosis of SCD: homozygous sickle cell disease, hemoglobin-SC, Sβ-thalassemia, hemoglobin-SO or hemoglobin-SD.
3. Patients not on a chronic exchange transfusion program for at least 60 days.
4. If patients are on a SCD drug (e.g. hydroxyurea, glutamine, or P-selectin inhibitors), the doses must be stable for at least 60 days prior to randomization. At the time of randomization, participants must be off Oxbryta for at least 30 days.
5. Any one of the following vasculopathy biomarker clinical results (a, b, c, d or e) measured in the last 24 months before randomization that indicates a high-risk patient:
6. Both a TRV 2.5- \<3.0 m/sec and NT-proBNP plasma level ≥ 160 pg/mL,
7. TRV ≥ 3.0 m/sec,
8. Both a mean pulmonary artery pressure (PAP) by right heart catheterization 20-24 mmHg and NT-proBNP plasma level ≥ 160 pg/mL,
9. Mean PAP by right heart catheterization ≥ 25 mmHg,
10. Chronic kidney disease (CKD) due to SCD with abnormal measures on 2 separate occasions as defined by: macroalbuminuria (albumin to creatinine ratio (ACR) \>300 mg/g) or proteinuria (protein to creatinine ratio \>30 mg/mmol), or estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2. (It is recommended that local laboratories use Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation without ethnic factors when estimating and reporting GFR). Clinical results of these biomarkers measured locally at sites within 24 months prior to randomization are acceptable to determine eligibility. TRV, PAP, NT-proBNP, albumin to creatinine ratio, protein to creatinine ratio, or eGFR values must be measured in a steady state (defined as measured ≥ 14 days since an acute care pain event) on different days. vi. Written informed consent obtained from patient to participate in the trial.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (23 Sites)

• University of Alabama — Tuscaloosa, Alabama
• UCSF Benioff Children's Hospital Oakland — Oakland, California
• Howard University Center for Sickle Cell Disease — Washington D.C., District of Columbia
• Emory University — Atlanta, Georgia
• University of Illinois at Chicago — Chicago, Illinois
• University of Maryland — Baltimore, Maryland
• Johns Hopkins University — Baltimore, Maryland
• Boston Medical Center — Boston, Massachusetts
• Washington University-St. Louis — St Louis, Missouri
• Icahn School of Medicine at Mount Sinai — New York, New York
• Montefiore Medical Center — New York, New York
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
• Atrium Health — Charlotte, North Carolina
• Duke University — Durham, North Carolina
• East Carolina University — Greenville, North Carolina
• University Hospitals Cleveland Medical Center — Cleveland, Ohio
• Ohio State University — Columbus, Ohio
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
• University of Texas Health Science Center at Houston — Houston, Texas
• Virginia Commonwealth University — Richmond, Virginia
• Hemorio — Rio de Janeiro,
• Kremlin-Bicêtre — Créteil,
• Henri Mondor Hopital — Paris,

💰 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 § 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.