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

Study point of contact

Nydia Chien, MSN
412-647-2791
[email protected]
Jude Jonassaint, RN
919-219-7481
[email protected]

Locations

9 United States sites

Age

> 18 Years

Phase

Phase 3

Study type

Interventional

Gender

All

Interventions

Biological

Other

Compensation

Unknown

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.

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, or c) measured
in the 13 months before randomization that indicates a high-risk patient:

1. Both a TRV 2.5-2.9 m/sec and NT-proBNP plasma level ≥ 160 pg/mL

2. TRV ≥ 3.0 m/sec

3. 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

  • Tuscaloosa, Alabama, United States, University of Alabama, 35401 [Recruiting]
  • Oakland, California, United States, UCSF Benioff Children's Hospital Oakland, 94609 [Recruiting]
  • Atlanta, Georgia, United States, Emory University, 30322 [Recruiting]
  • Chicago, Illinois, United States, University of Illinois at Chicago, 60607 [Recruiting]
  • Boston, Massachusetts, United States, Boston Medical Center, 02118 [Not yet recruiting]
  • Durham, North Carolina, United States, Duke University, 27708 [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 [Not yet recruiting]

More info

View on ClinicalTrials.gov
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