Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion in Cancer Patients

Phase 3

Completed

• Conditions: Cancer; Surgery

• Registration Number: NCT00180869
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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).

Study Timeline

• Study Start: 1997-09
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Last Update Submitted: 2005-09-12
• Study First Posted: 2005-09-16
• Last Update Posted: 2005-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Surgery for cancer with a transfusion during surgery risk greater than 30%
• Surgery in curative intent
• Written informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Polarization of lymphocyte responses towards a Th2 response following transfusion during surgery as assessed by the IL-4/IFN-γ ratio

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institut Gustave Roussy; 🇫🇷 Villejuif, France