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Evaluate the Efficacy and Safety of RBCs Derived from Mirasol-treated Whole Blood Compared with Conventional RBCs in Patients Requiring Chronic Transfusion Support (PRAISE Trial)

Clinical Trial Details

Thalassemia is an inherited (i.e., passed from parents to children through genes) blood disorder caused when the body doesn’t make enough of a protein called hemoglobin, an important part of red blood cells. When there isn’t enough hemoglobin, the body's red blood cells don’t function properly and they last shorter periods of time, so there are fewer healthy red blood cells traveling in the bloodstream. To help treat thalassemia symptoms, some people need frequent red blood cell transfusions. Some of the donor’s blood called white blood cells that remain in the donated red blood cell product. White blood cells can cause you to react to the transfusion. Sometimes the white blood cells in the donor blood attack the cells in your body. Terumo BCT has developed a research medical device called the Mirasol PRT System for whole blood (referred to as Mirasol in this form). Based on results from laboratory testing, this system is expected to inactivate the white blood cells (keep them from attacking the cells in your body) and may also propose to reduce the pathogens that may be in the donated blood. This study is being done to find out if the hemoglobin levels in your blood are different after receiving red blood cells taken from Mirasol-treated whole blood (called “MIR” in this study) compared to red blood cells from industry standard practices (called “REF” in this study).The Mirasol PRT System for whole blood is considered an investigational device, and it has not been approved by the United States Food and Drug Administration (FDA). 

Key Eligibility: 

   -Boys/Girls and Men/Women 12 or older 
   -Receiving transfusions every 2-4 weeks 
   -Detailed eligibility will be discussed/reviewed with the study team 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Arelys M. Rocha
(212) 746-3423
arr7008@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1603017083

Status

Not Yet Recruiting

Age Group

Adult , Pediatric

Disease