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

About the study

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.

Study point of contact

Nydia Chien, MSN
412-647-2791
chienn@upmc.edu
Jude Jonassaint, RN
919-219-7481
jonas@pitt.edu

Locations

18 United States sites

1 France site

1 United Kingdom site

Age

> 18 Years

Phase

Phase 3

Study type

Interventional

Gender

All

Interventions

Biological

Other

participation requirements

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 2 months.
If patients are on hydroxyurea, glutamin, or selectin inhibitors the doses must be stable for at least 2 months prior to randomization.

Any one of the following vasculopathy biomarker clinical results (a, b, c, d, or e) measured in the 13 months before randomization that indicates a high-risk patient:

Both a TRV 2.5-2.9 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 macroalbuminuria (albumin creatinine ratio (ACR) >300 mg/g) on 2 occasions, or proteinuria (protein creatinine ratio >30 mg/mmol) on 2 occasions, or estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 calculated on 2 occasions. Written informed consent obtained from patient to participate in the trial.

participation restrictions

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

Locations

  • Paris, France, Henri Mondor Hopital [Not yet recruiting]
  • Tuscaloosa, Alabama, United States, University of Alabama, 35401 [Recruiting]
  • Oakland, California, United States, UCSF Benioff Children's Hospital Oakland, 94609 [Recruiting]
  • Washington, District of Columbia, United States, Howard University Center for Sickle Cell Disease, 20060 [Recruiting]
  • Atlanta, Georgia, United States, Emory University, 30322 [Recruiting]
  • Chicago, Illinois, United States, University of Illinois at Chicago, 60607 [Recruiting]
  • Baltimore, Maryland, United States, Johns Hopkins University, 21206 [Recruiting]
  • Boston, Massachusetts, United States, Boston Medical Center, 02118 [Recruiting]
  • Saint Louis, Missouri, United States, Washington University-St. Louis, 63110 [Recruiting]
  • New York, New York, United States, Icahn School of Medicine at Mount Sinai, 10029 [Recruiting]
  • New York, New York, United States, Montefiore Medical Center, 10461 [Not yet recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill, 27599 [Recruiting]
  • Charlotte, North Carolina, United States, Atrium Health, 28204 [Recruiting]
  • Durham, North Carolina, United States, Duke University, 27708 [Recruiting]
  • Greenville, North Carolina, United States, East Carolina University, 27834 [Recruiting]
  • Columbus, Ohio, United States, Ohio State University, 43210 [Recruiting]
  • Pittsburgh, Pennsylvania, United States, University of Pittsburgh Medical Center, 15232 [Recruiting]
  • Houston, Texas, United States, University of Texas Health Science Center at Houston, 77030 [Recruiting]
  • Richmond, Virginia, United States, Virginia Commonwealth University, 23284 [Recruiting]
  • London, United Kingdom, Imperial College Healthcare NSH Trust-Hammersmith Hospital, W12 0HS [Not yet recruiting]
Last updated 2022-08-23