ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-02-26

Study Completion:2026-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04084080

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

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 Locations (Sites)

University of Alabama

Tuscaloosa, Alabama, 35401

United States

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609

United States

Howard University Center for Sickle Cell Disease

Washington, District of Columbia, 20060

United States

Emory University

Atlanta, Georgia, 30322

United States

University of Illinois at Chicago

Chicago, Illinois, 60607

United States

University of Maryland

Baltimore, Maryland, 21201

United States

Johns Hopkins University

Baltimore, Maryland, 21206

United States

Boston Medical Center

Boston, Massachusetts, 02118

United States

Washington University-St. Louis

St. Louis, Missouri, 63110

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Montefiore Medical Center

New York, New York, 10461

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

United States

Atrium Health

Charlotte, North Carolina, 28204

United States

Duke University

Durham, North Carolina, 27708

United States

East Carolina University

Greenville, North Carolina, 27834

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Ohio State University

Columbus, Ohio, 43210

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232

United States

University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

Virginia Commonwealth University

Richmond, Virginia, 23284

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-26

Study Completion Date2026-05-31

Study Record Updates

Study Start Date2020-02-26

Study Completion Date2026-05-31

Terms related to this study

Additional Relevant MeSH Terms

Sickle Cell Disease