SCD-CARRE (Sickle Cell Disease)

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.

Who Can Participate?

Eligibility

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 Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

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

Study Website

Study Website

Principal Investigator

Marilyn
Telen

Protocol Number

PRO00104840

NCT ID

NCT04084080

Enrollment Status

Open to Enrollment
ClinicalTrials.gov