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
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.
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
Principal Investigator
Marilyn
Telen
Protocol Number
PRO00104840
NCT ID
NCT04084080
Enrollment Status
Open to Enrollment