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. 2015 Dec 3;2015(12):CD009745. doi: 10.1002/14651858.CD009745.pub2

NCT00810810.

Methods Study design: Parallel group RCT
Allocation: Randomized
Endpoint classification: Efficacy study
Intervention model: Parallel assignment
Masking: Single blind (Investigator)
Primary purpose: Prevention
Participants Inclusion criteria:
  • At least 18 years 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 randomisation.

  • Immunosuppressive treatment.

  • Refuse blood transfusion.

  • Disease or condition placing subject at undue risk or decision of attending doctor.


Condition requiring high volume transfusion therapy.
Interventions Active comparator 1:
Standard blood components
Transfusion, if ordered by physician, with unfiltered RBCs and apheresis platelets
Experimental 2:
Leukoreduced blood components
Transfusion, if ordered by a physician, of leukoreduced RBCs and apheresis platelets
Experimental: 3
Leukoreduced and irradiated
Transfusion, if ordered by physician, of gamma irradiated leukoreduced RBCs and gamma irradiated apheresis platelets
Outcomes Primary outcomes:
  • Production, de novo, of antibody to HLA antigens (Time frame: 0 to 5 weeks after surgery).


Secondary outcomes:
  • Changes in number or cytokine profile of CD4 T regulatory cells or NKT cells.


(Time frame: 0 to 5 weeks after surgery)
Notes This study has been completed, but we did not find any publication related to it in the search.
Inclusion or exclusion decision cannot be made because sufficient information is not currently available.