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There is evidence to suggest that red blood cell concentrate (RBC) transfusion may have immunomodulatory effects. The aim of this randomized single-center trial is to compare immune responses in patients undergoing cancer surgery and given either an unmodified RBC (UN-RBC) or a leuko-reduced RBC (LR-RBC) transfusion perioperatively.
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, ï€¬ï€ 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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transfusion of allogeneic red blood cell concentrate | Procedure | |||
| transfusion of leuko-reduced red blood cell concentrate | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Polarization of lymphocyte responses towards a Th2 response following transfusion during surgery as assessed by the IL-4/IFN-γ ratio |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral blood mononuclear cell phenotyping | ||
| Cytokine production | ||
| Microchimerism at day 3 after transfusion during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valerie Lapierre, PhD | Gustave Roussy, Cancer Campus, Grand Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Gustave Roussy | Villejuif | 94800 | France |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Alteration of T cell repertoire |
| Incidence of nosocomial infection |
| Survival |