A Randomized Study of Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion During Surgery in Cancer Patients
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Polarization of lymphocyte responses towards a Th2 response following transfusion during surgery as assessed by the IL-4/IFN-γ ratio
- Status
- Completed
- Last Updated
- 20 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Polarization of lymphocyte responses towards a Th2 response following transfusion during surgery as assessed by the IL-4/IFN-γ ratio
Secondary Outcomes
- 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