A Randomized Study of Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion During Surgery in Cancer Patients
This single-center study is conducted to compare the effect of peroperative transfusion of
allogeneic unmodified RBC (UN-RBC) versus leuko-reduced RBC (RED-RBC) on recipient immunity.
Patients undergoing cancer surgery are randomly assigned peroperatively to receive UN-RBC or
RED-RBC. Groups are stratified for age, sex, tumor characteristics, prior transfusion and
prior cancer treatment. Blood sampless are collected before anesthesia (d0) and at days 3,
7, 14 , 28 after transfusion/surgery and analyzed for complete cell blood count, lymphocyte
subsets, cytokine production (IL4, IL10, IFNgamma, IL12), T-cells repertoire (TCR)
analysis and detection of circulating donor cells. Main study endpoint is the influence of
the treatment arm on IL4/IFNgamma ratio. The effect of transfusion type on any given
biological parameters is also tested (peripheral blood mononuclear cell phenotyping (PBMC),
cytokine production by stimulated PBMC, T cell repertoire analysis and microchimerism
assessment).
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Polarization of lymphocyte responses towards a Th2 response following transfusion during surgery as assessed by the IL-4/IFN-γ ratio
Valerie Lapierre, PhD
Principal Investigator
Gustave Roussy, Cancer Campus, Grand Paris
France: Ministry of Health
TRANSFUGE
NCT00180869
September 1997
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