Immunomodulation Following Transfusion
Condition: Blood Component Transfusion
Intervention: Standard blood components; Leukoreduced blood components; Leukoreduced and irradiated
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Individuals who consented for study were scheduled for cardiac surgery. They were randomized to one of three arms to receive blood components prepared by different, but clinically acceptable processes. If they required transfusion from 2 days prior to surgery until 30 days post surgery they received study product. Blood samples were collected prior to surgery and at two points after surgery.
Masking: Double (Investigator, Outcomes Assessor)
Masking description: Clinical teams caring for patients were not masked. Laboratory personnel were masked until all testing completed.
Enrollment: 287.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Blood Component Transfusion; Leukoreduction; HLA antibody; Immunosuppression

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 year of age

          -  Scheduled for open heart surgery of cardiopulmonary bypass that involves: CABG, CABG
             with valve, aneurysm repair

          -  Urgent or elective surgery

        Exclusion Criteria:

          -  Scheduled for open heart surgery of cardiopulmonary bypass that involves: placement of
             a ventricular assist device, cardiac transplantation, aortic dissection repair

          -  Emergent surgery

          -  participation in other clinical research studies within 30 days of randomization.

          -  Immunosuppressive treatment.

          -  Refuse blood transfusion

          -  Disease or condition placing subject at undue risk or decision of attending doctor.

          -  Condition requiring high volume transfusion therapy