Cancer, Surgery
Conditions
Keywords
cancer, peroperative transfusion, allogeneic red blood cell concentrate, leuko-reduced red blood cell concentrate
Brief summary
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.
Detailed description
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).
Interventions
PROCEDUREtransfusion of allogeneic red blood cell concentrate
PROCEDUREtransfusion of leuko-reduced red blood cell concentrate
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Surgery for cancer with a transfusion during surgery risk greater than 30% * Surgery in curative intent * Written informed consent
Exclusion criteria
* contraindications to the use of allogeneic unmodified red blood cell concentrate * any anti-RBC and/or anti-HLA and/or anti-granulocyte alloimmunization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Polarization of lymphocyte responses towards a Th2 response following transfusion during surgery as assessed by the IL-4/IFN-γ ratio | — |
Secondary
| Measure | Time frame |
|---|---|
| Peripheral blood mononuclear cell phenotyping | — |
| Cytokine production | — |
| Microchimerism at day 3 after transfusion during surgery | — |
| Alteration of T cell repertoire | — |
| Incidence of nosocomial infection | — |
| Survival | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORValerie Lapierre, PhD
Gustave Roussy, Cancer Campus, Grand Paris
Outcome results
None listed