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
412-692-2086
[email protected]

Locations

1 United States site

Age

> 18 Years

Phase

Phase 3

Study type

Interventional

Gender

All

Interventions

Biological

Other

Compensation


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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.

study 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 results (a, b, or c) that indicates a
high-risk patient patient measured in the 12 months before randomization:

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 (>300 mg albumin
per gram creatinine) confirmed by 2 repeat measurements, or proteinuria (protein
creatinine ratio >30 mg/mmol) confirmed by 2 positive results, or estimated
glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 calculated on 2 occasions Biomarkers used for eligibility are based on local clinical site readings. TRV, NT-proBNP, albumin to creatinine ratio, protein creatinine ratio, or eGFR values must be measured in a steady state (defined as measured ≥ 14 days since an acute care pain event) within 12 months prior to randomization. - Written informed consent obtained from patient to participate in the trial.

study participation exclusions

– 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

– 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 Screening

Location

  • University Of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15232 [Not yet recruiting]

More info

View on ClinicalTrials.gov
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