Phase 3 trial testing red blood cell exchange in SCD still enrolling
Study began in 2020 with a $19.2M grant from NIH
A Phase 3 clinical trial evaluating whether adding red blood cell exchange to standard-of-care improves outcomes for adults with high-risk sickle cell disease (SCD) is still recruiting at sites across the U.S., as well as in France and Brazil.
The study, called Sickle Cell Disease and CardiovAscular Risk Red Cell Exchange, or SCD-CARRE (NCT04084080), began in 2020 with the support of a $19.2 million grant from the U.S. National Institutes of Health. It’s enrolling up to 150 patients with a high mortality risk, which will be assessed based on biomarkers indicative of cardiovascular, cardiopulmonary, or chronic kidney problems.
“Approximately 30 percent of patients with sickle cell disease develop serious organ damage, such as cardiopulmonary complications, and kidney or liver failure, with the risks steadily increasing with age,” Mark T. Gladwin, MD, the trial’s sponsor and the dean of the University of Maryland School of Medicine, said in a university press release. “The goal of the study is to determine whether red cell exchange can lower deaths, reduce hospitalizations, and slow down or reverse the development of major end-stage organ damage.”
The researcher recently presented an update on the trial’s enrollment at an SCD symposium at HEMORIO, a hematology research and transfusion center in Rio de Janeiro, Brazil, and the country’s single trial site.
A difference with red blood cell exchange transfusions
Blood transfusions are commonly used to treat acute SCD complications, but they can result in iron toxicity.
In red blood cell exchange transfusions, sickled cells are separated and removed from a patient’s blood and then replaced with healthy ones collected from donors. The process takes longer than a regular blood transfusion, is more expensive, and requires more donor blood.
In SCD-CARRE, which is being co-led by researchers at University of Pittsburgh Medical Center, participants will be randomly assigned to receive standard SCD treatment either alone or with monthly automated red blood cell exchange transfusions for a year.
The trial’s main goal is to assess group differences in the total number of clinical worsening episodes that require healthcare visits or that lead to death after about a year. Secondary goals include differences in SCD-related acute events and major complications, as well as survival, exercise capacity, cardiovascular function, and risk. SCD-specific patient reported outcomes, including pain and quality of life, will also be assessed.
The trial is touted as the largest of its kind to assess the effectiveness of red blood cell exchange transfusions in prolonging life and slowing or reversing organ damage.