Active — Not RecruitingPhase 3

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

United States173 participantsStarted 2020-02-26

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Both a TRV 2.5- \<3.0 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 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).

What they're measuring

Episodes of clinical worsening

Timeframe: 13 months

Trial details

NCT IDNCT04084080

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31

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