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

Description

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.

Conditions

Sickle Cell Disease
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Sickle Cell Disease

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Sickle Cell Disease
Intervention / Treatment

-

Contacts and Locations

Tuscaloosa

University of Alabama, Tuscaloosa, Alabama, United States, 35401

Oakland

UCSF Benioff Children's Hospital Oakland, Oakland, California, United States, 94609

Washington

Howard University Center for Sickle Cell Disease, Washington, District of Columbia, United States, 20060

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Chicago

University of Illinois at Chicago, Chicago, Illinois, United States, 60607

Baltimore

University of Maryland, Baltimore, Maryland, United States, 21201

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21206

Boston

Boston Medical Center, Boston, Massachusetts, United States, 02118

St. Louis

Washington University-St. Louis, St. Louis, Missouri, United States, 63110

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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:
  • 1. Both a TRV 2.5- \<3.0 m/sec and NT-proBNP plasma level ≥ 160 pg/mL,
  • 2. TRV ≥ 3.0 m/sec,
  • 3. Both a mean pulmonary artery pressure (PAP) by right heart catheterization 20-24 mmHg and NT-proBNP plasma level ≥ 160 pg/mL,
  • 4. Mean PAP by right heart catheterization ≥ 25 mmHg,
  • 5. 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).
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pittsburgh,

Mark Gladwin, MD, STUDY_CHAIR, University of Maryland

Darrell Triulzi, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Maria Brooks, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2026-05-31