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

Running, not enrolling · Phase 3

Conditions studied: Sickle Cell Disease

In brief

The SCD-CARRE trial is a Phase 3, prospective, randomized, multicenter, controlled, parallel two-arm study aimed to determine if automated exchange blood transfusion and standard of care administered to high mortality risk adult SCD patients reduces the total number of episodes of clinical worsening of SCD requiring acute health care encounters (non-elective infusion center/ER/hospital visits) or resulting in death over 12 months as compared with standard of care.

Key facts

Study ID

NCT04084080

Run by

University of Pittsburgh

People needed

173

Starts

2020-02-26

Expected to finish

2026-07-31

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Diagnosis of SCD: homozygous sickle cell disease, hemoglobin-SC, Sβ-thalassemia, hemoglobin-SO or hemoglobin-SD.
• Patients not on a chronic exchange transfusion program for at least 60 days.
• 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.
• 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:
• Both a TRV 2.5- <3.0 m/sec and NT-proBNP plasma level ≥ 160 pg/mL,
• TRV ≥ 3.0 m/sec,
• Both a mean pulmonary artery pressure (PAP) by right heart catheterization 20-24 mmHg and NT-proBNP plasma level ≥ 160 pg/mL,
• Mean PAP by right heart catheterization ≥ 25 mmHg,
• 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.

You may not qualify if…

• RBC alloimmunization resulting in inability of blood bank to obtain compatible components for chronic exchange transfusions
• Previous history of hyper-hemolysis syndrome
• Previous history of severe transfusion reaction resulting in renal failure or due to serious complications such as hypotension or respiratory distress
• More than 10 vaso-occlusive episodes in the past 12 months requiring admission to a hospital to receive treatment.
• Religious objection to receiving blood transfusion
• Diagnosis of ischemic stroke within the past 6 months
• Clinical evidence of liver failure or advanced cirrhosis or any co-existing medical condition that in the Investigator's judgement will substantially increase the risk associated with the patient's participation in the trial
• Women of childbearing potential who have a positive pregnancy test at baseline

Where it is running

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

Full record on ClinicalTrials.gov

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