At a glance
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Immunomodulation Following Transfusion
In Brief
A Phase 4 clinical trial evaluating Standard blood components, Leukoreduced blood components, and 1 other intervention for Blood Component Transfusion. Completed, enrolled 287 participants across 2 sites.
Detailed Summary
This study is designed to provide information on patients' immune response after exposure to transfused blood. Blood transfusions may have opposite immune effects on patients. One is sensitization. The other is immunosuppression. The magnitude of these effects in patients who are not on chemotherapy is unknown. These effects are thought to be due largely to white blood cells present in the transfusion product. "Leukofiltration" and "gamma-irradiation" are the special treatments that deplete white blood cells. A combination of leukofiltration and gamma-irradiation pretreatment of donor blood is thought to deplete the white blood cells most effectively. In this study, patients scheduled for cardiac surgery are randomly assigned to receive blood products pretreated in one of three ways: untreated, filtered or filtered and irradiated. If their physician orders transfusions, they will receive products assigned to their group. Patients are asked to provide two blood samples during the 4 weeks after surgery. Studies will measure changes in antibody to HLA and in cells that regulate the immune response. The levels of sensitization and immunosuppression will be correlated to the transfusion products received.
Study Details
Timeline
Interventions
Transfusion, if ordered by physician, with unfiltered red blood cells and apheresis platelets
Transfusion, if ordered by a physician, of leukoreduced red blood cells and apheresis platelets
Transfusion, if ordered by physician, of gamma irradiated leukoreduced red blood cells and gamma irradiated apheresis platelets