SCD-CARRE (Sickle Cell Disease) - Clinical Trial

What is the Purpose of this Study?

We are doing this to see the effects of giving long-term red blood cell exchange transfusion to patients with sickle cell disease (SCD). We want to know if exchange blood transfusion may help with serious complications of SCD or reduce the chances of a new, serious problem happening.

What is the Condition Being Studied?

Sickle Cell Disease (SCD)

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with SCD: hemoglobin SS, SC, Sβ0 thalassemia, Sβ+ thalassemia, SO, SO-Arab, or SD
  • Have not changed their dose of SCD medication (e.g., hydroxyurea, glutamine, or P-selectin inhibitors) in the past 60 days
  • Do not have any evidence of severe/significant cardiovascular or kindey problems related to SCD

For more information about who can join this study, please contact the study team at lindsey.muller@duke.edu.

Age Group
Adults

What is Involved?

Usual care, or standard of care, is the plan a physician should follow when caring for patients. We will compare the usual care for SCD on its own to exchange blood transfusion + usual care. We want to know what effects exchange transfusion has on cardiovascular and kidney complications that can be caused by SCD.

If you are eligible for the study, a computer program will randomly assign you to 1 of 2 study groups.

  • Group 1 will get the usual care for SCD, as chosen by your doctor.
  • Group 2 will get an exchange transfusion every 3-6 weeks for 12 months, plus the usual care SCD.

Everyone in the study will have tests, exams, and blood draws every month, and will complete an echocardiogram, walk test, activity monitoring, and quality of life and pain questionnaires every 4 months throughout the study. The study will last about 13 months.

Study Details

Full Title
Sickle Cell Disease and CardiovAscular Risk - Red cell Exchange Trial (SCD-CARRE)
Principal Investigator
Protocol Number
IRB: PRO00104840
NCT: NCT04084080
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
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